Atlas FDA

GTJ

16 FDA 510(k) clearances · Product code

73 daysmedian time to decision
295 days90th percentile
16clearances measured

FDA profile

Official device name
Antisera, All Groups, N. Meningitidis
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3390
Medical specialty
Microbiology
Flags
Third-party review eligible
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RecordFirmDate
DIRECTIGEN MENINGITIS COMBO TEST (K952791)Bd Becton Dickinson Vacutainer Systems Preanalytic1996-05-30
DIRECTIGEN MENINGITIS COMBO TEST KIT (K915330)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-03-23
SLIDEX MENINGITE-KIT 5 (K910210)Vitek Systems, Inc.1991-08-12
BACTIGEN(R) N. MENINGITIDIS (K885004)Armkel, LLC1989-02-07
IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT (K870089)Microscan Div. Baxter Healthcare Corp.1987-03-17
WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 (K854851)Wellcome Diagnostics1986-02-04
WELLCOGEN BACTERIAL ANTIGEN KIT (K854852)Wellcome Diagnostics1986-02-04
PHADEBACT CSF TEST (K844999)Pharmacia, Inc.1985-10-17
WILLCOGEN MENINGITIDIS KIT ZL25 (K851691)Wellcome Diagnostics1985-06-10
MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51 (K844762)Wellcome Diagnostics1985-06-04
DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST (K844407)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-01-25
BACTIGEN - N.MENNINIGITIDIS TEST (K841907)Armkel, LLC1984-07-06
WELLCOGEN N. MENINGITIDIS A,C,Y W135 (K833063)Wellcome Diagnostics1984-01-10
BACTIGEN-N. MENINGITIDIS (K823880)Armkel, LLC1983-03-09
PHADEBACT CSF TEST 20 (K822810)Pharmacia, Inc.1982-12-30
AGGLUTINATING SERUM W135 (K771562)Burroughs Wellcome Co.1977-08-25

Track GTJ automatically

Every clearance here is in the API, with alerts when new ones post.