{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system"
      ],
      "establishment_type": [
        "Complaint File Establishment per 21 CFR 820.198",
        "Develop Specifications But Do Not Manufacture At This Facility"
      ],
      "registration": {
        "registration_number": "3025772277",
        "fei_number": "3025772277",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "AFFINITY BIOSENSORS",
        "address_line_1": "222 E Canon Perdido St Ste 101",
        "address_line_2": "",
        "city": "Santa Barbara",
        "state_code": "CA",
        "iso_country_code": "US",
        "zip_code": "93101",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "Affinity Biosensors",
          "owner_operator_number": "10091217",
          "official_correspondent": {
            "first_name": "Ken",
            "middle_initial": "",
            "last_name": "Babcock",
            "subaccount_company_name": "",
            "phone_number": "1-805-4508076-x"
          },
          "contact_address": {
            "address_1": "222 E Canon Perdido Street",
            "address_2": "Suite 101",
            "city": "Santa Barbara",
            "state_code": "CA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "93101"
          }
        }
      },
      "pma_number": "",
      "k_number": "K211815",
      "products": [
        {
          "product_code": "LON",
          "created_date": "2024-07-25",
          "owner_operator_number": "10091217",
          "exempt": "",
          "openfda": {
            "device_name": "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.1645",
            "device_class": "2"
          }
        },
        {
          "product_code": "SAN",
          "created_date": "2024-07-25",
          "owner_operator_number": "10091217",
          "exempt": "",
          "openfda": {
            "k_number": [
              "K211815"
            ],
            "device_name": "Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.1650",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}