{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "third_party_flag": "N", "city": "Los Angeles", "advisory_committee_description": "Clinical Chemistry", "address_1": "5210 Pacific Concourse Dr.", "address_2": "", "statement_or_summary": "Summary", "product_code": "JJX", "openfda": { "registration_number": [ "3009129531", "3011325031", "3016863723", "3033967997", "3007662974", "1122236", "3008344661", "3016774562", "3004637226", "8020888", "1219029", "3003539867", "1000134386", "3021090658", "2915274", "2432235", "3007349751", "3011979858", "3014680791", "3014607865", "3005625991", "3008156187", "1810909", "3010131137", "9610806", "3009189893", "3003522182", "3005450604", "3021611414", "9616936", "3042026207", "3015997711", "3003561301", "3004145393", "3008959428", "2133810", "3003559191", "3008789114", "3003917514", "3014353121", "3004152597", "3006644620", "8043909", "2032098", "2024800", "2032087", "3004193489", "1226774", "2050012", "3008700497", "3003982601", "1220972", "3009901017", "3009171251", "9612316", "1832216", "1218959", "3004009431", "1618982", "8032314", "3009092698", "1063851", "3012104670", "3013160357", "3003951180", "3005621222", "3012113276", "1066444", "9610566", "3007652384", "2432495", "1825740", "3008606429", "2032682", "1000115322", "9610529", "1119779", "2247288", "3004529019", "3007111389", "3004167884", "2032900", "2016706", "3030978471", "3003422726", "2133772", "8043889", "3016438761", "3007137761", "3003871639", "3001452053", "3005847079", "1319808", "3003419906", "3033751096", "3007886372", "1643621", "3002642396", "2435505", "9610102", "2020715", "3010713600", "3000308930", "1827821", "3018940143", "2246703", "2024674", "2122870", "3013982035", "3009746061", "3011393376", "3013472743", "3004434309", "3015347724", "3027062375", "3006371704", "8023018", "2245285", "3005529799", "3013223546", "3012133212", "3007088335", "3005643513", "3015972771", "3015525148", "2245451", "9614373", "3003423869", "9616530", "3007363438", "3006198300", "3012348571", "1217183", "3002807722", "3007710663", "3004176168", "8021924", "3002806944", "9611444", "3002895169", "2084025", "3012422258", "3007134734", "3010939897", "3010864358", "1319809", "3009491259", "3004493545", "1318354", "3009518015", "3004130086", "3008780388", "2026994", "3004146366", "3012963943", "3003593973", "1415939", "1220649", "3016698405", "3017772438", "3017550662", "3003741796", "3002800697", "3014353045", "9681576", "1717966", "3011420269", "3005798905", "9616673", "3008877272", "3033507883", "3032705", "3010830834", "1122376", "9710337", "3003749380", "3004973408", "3038419886", "3003132490", "3003460426", "3007118747", "3002792284", "2023365", "3005644014", "9613069", "3026260647", "1219913", "3008514395", "2123774", "3013059683", "3000148879", "3011121740", "8020316", "9610099", "3030186688", "9681518", "3004183148", "3042301847", "2954323", "3002809144", "3005333358", "3017520431", "3012118659", "2085064", "3007499349", "3011989923", "1720929", "3003674698", "1722684", "3037000637", "9610240", "9610746", "3021841051", "1616487", "3006532271", "8031673", "3001058982", "3005393828", "3017500903", "2050010", "1319681", "3031259044", "2155", "2250051", "2182595", "1450743", "2030538", "3005862821", "1832816", "9615507", "3013660430", "2030633", "3005094123", "1649661", "3014279513", "1000403749", "3007382160", "1000113657", "3005395953", "3002637618", "3003610890", "3015188281", "3020885868", "8023024", "2531491", "3006755541", "9681753", "9610126", "9710492", "3010127294", "3014150341", "3024512705", "3003902721", "9615837", "3006948883", "3009469260", "1181121", "2245578", "3012494290", "3010534606", "3011213605", "3010152370", "2521625", "2030861", "3003985394", "3012471076", "1645225", "2434178", "3003600763", "3002694097", "9615777" ], "fei_number": [ "3009129531", "3011325031", "3016863723", "3033967997", "3007662974", "1122236", "3008344661", "3002806559", "3016774562", "3004637226", "1219029", "3004445302", "1000220650", "1000134386", "3021090658", "1000305841", "2432235", "2915274", "3007349751", "3011979858", "3014680791", "3014607865", "3005625991", "3008156187", "1810909", "3010131137", "3009189893", "3003522182", "3005450604", "3021611414", "3005695774", "3042026207", "3015997711", "3003561301", "3004145393", "3008959428", "3002701146", "3003559191", "3008789114", "3003917514", "3014353121", "3004152597", "3006644620", "2024800", "3004193489", "3000209794", "3003045237", "2050012", "3008700497", "3003982601", "1220972", "3009901017", "6387", "1832216", "3003355251", "1218959", "3006759904", "3004009431", "1618982", "3009092698", "3012104670", "3013160357", "3003951180", "3005621222", "3012113276", "3007652384", "2432495", "3002806557", "3000210620", "3011774813", "3008606429", "1000115322", "1825740", "1119779", "1000118544", "3004173703", "3004529019", "3007111389", "3004167884", "2016706", "3000215862", "3004525092", "3030978471", "3003422726", "3007137761", "3016438761", "3006769061", "3003871639", "3007019572", "3001452053", "3005847079", "3003419906", "3033751096", "1000122044", "3007886372", "1643621", "3002642396", "3003407015", "3003572099", "2020715", "3010713600", "3000308930", "1827821", "3018940143", "2246703", "2024674", "2122870", "3013982035", "3009746061", "3011393376", "3013472743", "3003116995", "3004434309", "3015347724", "3027062375", "3006371704", "2245285", "3005529799", "3013223546", "3012133212", "3003500908", "3005643513", "3002808328", "3015972771", "3002698769", "2245451", "3003423869", "3006198300", "3012348571", "1000520007", "1217183", "3002807722", "3004176168", "3002485711", "3002806944", "3002895169", "3003952975", "2084025", "3012422258", "3000303338", "3007134734", "3010939897", "3010864358", "3002806778", "3009491259", "3002808140", "3002808340", "1318354", "3003058448", "3004493545", "3009518015", "3004130086", "3008780388", "2026994", "3004146366", "3012963943", "3003593973", "1415939", "1220649", "3016698405", "3017772438", "3017550662", "3003405786", "3003741796", "3002806560", "3002800697", "3014353045", "1717966", "3011420269", "3005798905", "3008877272", "3033507883", "3002546385", "3003749380", "3004973408", "1000136573", "3038419886", "3003132490", "3002671736", "3003460426", "1000305840", "3002792284", "3007118747", "2023365", "3002806809", "3005644014", "3026260647", "1219913", "3008514395", "3003206796", "2123774", "3013059683", "3000148879", "3002829675", "1000119795", "1220394", "3002807272", "3030186688", "3004183148", "3042301847", "3002809144", "3005333358", "3017520431", "3012118659", "3011989923", "1720929", "3002807423", "3002808212", "3003674698", "3037000637", "3001644026", "3002676602", "3021841051", "1616487", "3006532271", "3001058982", "3005393828", "3010700165", "3017500903", "3003179344", "2050010", "3001451797", "1000442352", "3031259044", "2155", "2250051", "2182595", "1450743", "3002608770", "3007034602", "1832816", "3005862821", "3013660430", "3002808498", "3005664575", "3005094123", "3014279513", "1000403749", "3007382160", "1000113657", "3005395953", "3000203066", "3002637618", "3003610890", "3015188281", "3020885868", "3002807876", "3006755541", "3003516723", "1000135102", "3010127294", "3014150341", "3024512705", "3003902721", "3006948883", "3009469260", "1181121", "2245578", "3012494290", "3010534606", "2967", "3011213605", "3010152370", "3002803444", "2521625", "3003985394", "3012471076", "2434178", "3003600763", "3002694097", "3002807786" ], "device_name": "Single (Specified) Analyte Controls (Assayed And Unassayed)", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1660", "device_class": "1" }, "zip_code": "90045", "applicant": "Siemens Healthcare Diagnostics, Inc.", "decision_date": "2015-02-25", "decision_code": "SESE", "country_code": "US", "device_name": "IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material", "advisory_committee": "CH", "contact": "Donna Velasquez", "expedited_review_flag": "", "k_number": "K143636", "state": "CA", "date_received": "2014-12-22", "review_advisory_committee": "CH", "postal_code": "90045", "decision_description": "Substantially Equivalent", "clearance_type": "Traditional" } ] }