FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
5497–5520 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared May 25, 1984
AMNIO STAT-FLM AGGLUTINATION TEST
K834616 · JHG
Hana Biologics, Inc.
Microbiology · 163d
Cleared May 25, 1984
CODE-A-WELL SERIES 200 PLATE
K841632 · LIB
Plastic Injectors, Inc.
Microbiology · 35d
Cleared May 25, 1984
SELECTIVE CULTURE MED. SELECTIVE STREP
K841839 · JSJ
Microline Scientific
Microbiology · 38d
Cleared May 25, 1984
SELECTIVE CULTURE MED. PHENYLETHYL ALCO
K841840 · JSJ
Microline Scientific
Microbiology · 38d
Cleared May 25, 1984
DIFFERENTIAL CULTURE MED. MANNITOL SALT
K841841 · JSI
Microline Scientific
Microbiology · 38d
Cleared May 22, 1984
EXTRACTABLE NUCLEAR ANTIGEN ASSAY
K840221 · LLL
Zeus Scientific, Inc.
Microbiology · 124d
Cleared May 22, 1984
CODE-A-WELL SERIES 300 PLATE
K841937 · LIB
Plastic Injectors, Inc.
Microbiology · 11d
Cleared May 21, 1984
CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-
K833447 · MCB
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 229d
Cleared May 21, 1984
TOXO-G EIA DIAGNOSTIC KIT
K840879 · LGD
Abbott Laboratories
Microbiology · 84d
Cleared May 21, 1984
RUBELLA IGG ANTIBODY ELISA TEST SYS
K841200 · LFX
Ortho Diagnostic Systems, Inc.
Microbiology · 61d
Cleared May 21, 1984
HAEMOPHILUS ISOLATION AGAR 2827
K841673 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 28d
Cleared May 21, 1984
ENRICHED CULTURE MED. FLUID THIOGLYC0
K841837 · KZI
Microline Scientific
Microbiology · 34d
Cleared May 21, 1984
ENRICHED CULTURE MED. TRYPTIC SOY AGAR
K841838 · KZI
Microline Scientific
Microbiology · 34d
Cleared May 14, 1984
BBL GASPAK POUCH
K841307 · FKJ
Bd Becton Dickinson Vacutainer...
Microbiology · 45d
Cleared May 14, 1984
SELENITE CYSTINE BROTH BASE
K841660
Oxoid U.S.A., Inc.
Microbiology · 21d
Cleared May 14, 1984
MUELLER-HINTON AGAR
K841755 · JTZ
The Montana Deaconess Medical Center
Microbiology · 17d
Cleared May 14, 1984
CULTURE MEDIUM FOR PATHOGENIC NEISSER
K841833 · JTY
Microline Scientific
Microbiology · 27d
Cleared May 14, 1984
CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP
K841834 · JTZ
Microline Scientific
Microbiology · 27d
Cleared May 14, 1984
MULTIPURPOSE CULTURE MEDIUM
K841835 · JSG
Microline Scientific
Microbiology · 27d
Cleared May 14, 1984
SELECTIVE CULTURE MED. TRICHOMONAS
K841836 · JSD
Microline Scientific
Microbiology · 27d
Cleared May 11, 1984
PRESTON CAMPYLOBACTER SELECTIVE SUPP
K840330 · JSK
Oxoid U.S.A., Inc.
Microbiology · 107d
Cleared May 11, 1984
LEGIONELLA MWY SELECTIVE SUPPLEMENT
K840331 · JSK
Oxoid U.S.A., Inc.
Microbiology · 107d
Cleared May 11, 1984
CAMPYLOBACTER AGAR BASE
K840332 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 107d
Cleared May 11, 1984
LEGIONELLA BMPA SELECTIVE SUPPLE
K840333 · JSK
Oxoid U.S.A., Inc.
Microbiology · 107d