{ "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": "2026-06-01", "results": { "skip": 0, "limit": 1, "total": 175149 } }, "results": [ { "third_party_flag": "N", "city": "Hialeah", "advisory_committee_description": "Hematology", "address_1": "440 Coulter Way", "address_2": "West 20th St.", "statement_or_summary": "", "product_code": "GKZ", "openfda": { "registration_number": [ "1950302", "3010960914", "8040564", "2919069", "3004008703", "3009711478", "3016438761", "3006412379", "3005333358", "3007750372", "3006198300", "1000292377", "3007349751", "3016090200", "3009297077", "1415939", "3013059683", "3002809144", "1064608", "2221819", "3000148879", "3013608230", "3010421384", "8020888", "1036362", "3003601075", "3010324880", "1181121", "1832816", "2914537", "3014053517", "3003423869", "3002759288", "9613959", "3009156722", "3003589956", "3009092698", "1221433", "2032112", "2182501", "3008425728", "3009189893", "3013445220", "8023018", "3006946274", "3006606827", "1063851", "1017835", "3011765035", "3038625004", "1061932", "3027394506", "3007603826", "3020704087", "9610099", "3009834076", "3008096179", "3039523350", "3009495621", "3008352382", "3003630693", "2432235" ], "fei_number": [ "1950302", "6137", "3010960914", "2919069", "3004008703", "3009711478", "3016438761", "3006412379", "3005333358", "3007750372", "3006198300", "1000292377", "3007019572", "3007349751", "3016090200", "3009297077", "3002808301", "1415939", "3013059683", "3002809144", "2221819", "3000148879", "3013608230", "3010421384", "3000203293", "1036362", "3003601075", "3010324880", "1181121", "1832816", "1000442352", "3014053517", "3003423869", "2914537", "3002759288", "3009156722", "3003589956", "1221433", "3009092698", "2182501", "3008425728", "3009189893", "3013445220", "3006946274", "3006606827", "1017835", "3002807272", "3011765035", "3038625004", "3027394506", "3007603826", "3020704087", "3003076831", "3009834076", "3008096179", "3002806778", "3039523350", "3009495621", "3008352382", "3003071743", "3003630693", "2432235" ], "device_name": "Counter, Differential Cell", "medical_specialty_description": "Hematology", "regulation_number": "864.5220", "device_class": "2" }, "zip_code": "33010", "applicant": "Coulter Immunology", "decision_date": "1990-03-02", "decision_code": "SESE", "country_code": "US", "device_name": "COULTER CLONE T4 MONOCLONAL ANTIBODY", "advisory_committee": "HE", "contact": "GREGORY BUTCHKO", "expedited_review_flag": "", "k_number": "K893852", "state": "FL", "date_received": "1989-05-25", "review_advisory_committee": "HE", "postal_code": "33010", "decision_description": "Substantially Equivalent", "clearance_type": "Traditional" } ] }