{ "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": "Y", "life_sustain_support_flag": "N", "gmp_exempt_flag": "N", "summary_malfunction_reporting": "Ineligible", "product_code": "JWY", "openfda": { "k_number": [ "K190914", "K934380", "K092445", "K911558", "K001953", "K022656", "K183031", "K200180", "K112276", "K020822", "K911305", "K922926", "K984087", "K180330", "K971694", "K911303", "K062022", "K014258", "K020748", "K182797", "K874466", "K150236", "K894514", "K013580", "K030933", "K081325", "K854103", "K930055", "K051202", "K960220", "K093741", "K861186", "K183033", "K864069", "K970210", "K182922", "K232310", "K961519", "K102668", "K021037", "K062816", "K922780", "K990722", "K974362", "K183115", "K033119", "K061687", "K863847", "K003868", "K041214", "K883555", "K990685", "K893977", "K021188", "K150556", "K152774", "K172542", "K203741", "K143381", "K895796", "K911392", "K021997", "K942267", "K983943", "K081182", "K854102", "K911186", "K924500", "K853805", "K193024", "K142338", "K941997", "K854097", "K861187", "K162854", "K242653", "K905853", "K133847", "K001516", "K944723", "K200512", "K864891", "K073653", "K020556", "K980348", "K910242", "K171870", "K883552", "K874727", "K896965", "K060783", "K043589", "K941317", "K032382", "K143288", "K182557", "K911185", "K093604", "K001573", "K250575", "K950328", "K982868", "K041534", "K210757", "K004045", "K073558", "K931069", "K183140", "K991925", "K032259", "K984144", "K943756", "K933885", "K161175", "K062841", "K925644", "K003834", "K862446", "K923045", "K192355", "K021627", "K970676", "K972180", "K012151", "K980338", "K854098", "K930469", "K911555", "K983259", "K180339", "K153687", "K951240", "K981136", "K971951", "K172150", "K972524", "K193538", "K854099", "K926294", "K953422", "K973695", "K870074", "K911559", "K955910", "K954319", "K180936", "K141000", "K981138", "K983565", "K981639", "K012895", "K230935", "K933709", "K192250", "K202612", "K001887", "K190154", "K223844", "K001558", "K021339", "K192050", "K153569", "K853862", "K926545", "K945997", "K173817", "K243169", "K252014", "K882477", "K883800", "K980335", "K163517", "K945433", "K896332", "K021169", "K904523", "K880598", "K863776", "K191809", "K983890", "K231988", "K151873", "K111615", "K152346", "K141651", "K081520", "K946126", "K932082", "K180886", "K881716", "K950123", "K062681", "K083606", "K910484", "K883394", "K912964", "K031545", "K854100", "K933849", "K020691", "K173209", "K970473", "K192729", "K882910", "K242657", "K992143", "K021181", "K243202", "K983922", "K984491", "K935485", "K242843", "K012921", "K020762", "K944651", "K252114", "K874426", "K911187", "K903589", "K010363", "K170892", "K896566", "K102535", "K922168", "K904689", "K013423", "K163298", "K971376", "K964236", "K001036", "K861584", "K042331", "K251580", "K894189", "K882912", "K946364", "K980342", "K934458", "K912846", "K000596", "K062839", "K992059", "K861408", "K993679", "K882301", "K983486", "K883551", "K864493", "K922458", "K951539", "K981134", "K020937", "K940917", "K951241", "K242021", "K860369", "K983252", "K910346", "K944517", "K850833", "K001547", "K944753", "K191908", "K012565", "K250856", "K181889", "K911557", "K013075", "K882909", "K031727", "K880641", "K884510", "K960989", "K971697", "K870663", "K941459", "K960991", "K242905", "K880430", "K912965", "K200308", "K021018", "K992108", "K980345", "K950817", "K241967", "K250990", "K001612", "K052091", "K183527", "K031205", "K093865", "K981137", "K911390", "K041776", "K964203", "K172274", "K190109", "K031103", "K171906", "K980603", "K883798", "K955920", "K242658", "K052366", "K020859", "K882029", "K062190", "K990297", "K874876", "K884831", "K961517", "K901598", "K911389", "K021445", "K020331", "K883549", "K133773", "K896278", "K983711", "K912778", "K983746", "K883554", "K042392", "K202423", "K142151", "K980877", "K191953", "K960235", "K895215", "K252062", "K970820", "K936305", "K060621", "K935519", "K862140", "K032706", "K040619", "K883548", "K170670", "K932917", "K883550", "K934323", "K844903", "K013925", "K911304", "K981139", "K011803", "K984581", "K140985", "K032518", "K020037", "K230479", "K001035", "K983571", "K884509", "K231994", "K023202", "K040846", "K021110", "K980773", "K862978", "K000298", "K983301", "K965190", "K862560", "K870719", "K911391", "K801805", "K972688", "K894146", "K943510", "K061536", "K983408", "K062783", "K992296", "K854101", "K143526", "K190252", "K020686", "K111429", "K910345", "K240445", "K981135", "K882299", "K170772", "K173307", "K962794", "K042390", "K181708", "K953223", "K951879", "K014259", "K860195", "K121002", "K033522", "K883076", "K232395", "K860753", "K172454", "K183324", "K882300", "K854525", "K022775", "K912613", "K983027", "K172109", "K963107", "K243201", "K882911", "K181946", "K073424", "K192345", "K963641", "K942089", "K883553", "K983953", "K880617", "K020162", "K972567", "K881846", "K902739", "K922003", "K933746", "K020820", "K854577", "K211672", "K984489", "K020938", "K242659", "K192738", "K980347", "K923684", "K250274", "K913459", "K960990", "K962867", "K911556", "K062722" ], "pma_number": [ "P830028" ], "registration_number": [ "9615754", "1119779", "2919016", "1924669", "1530126", "3013661582", "8021914", "3012389632" ], "fei_number": [ "1000515493", "1119779", "2919016", "1924669", "3002806332", "3013661582", "3012389632", "3008237827" ] }, "review_panel": "MI", "medical_specialty": "MI", "device_name": "Manual Antimicrobial Susceptibility Test Systems", "review_code": "", "unclassified_reason": "", "medical_specialty_description": "Microbiology", "device_class": "2", "definition": "", "regulation_number": "866.1640", "implant_flag": "N", "submission_type_id": "1" } ] }