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
5449–5472 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 11, 1984
STREP-A-CHEK
K842600 · JSF
E-Y Laboratories, Inc.
Microbiology · 8d
Cleared Jul 06, 1984
BACTIGEN - N.MENNINIGITIDIS TEST
K841907 · GTJ
Armkel, LLC
Microbiology · 59d
Cleared Jul 03, 1984
SPOTTEST LACTOPHENOL COTTON BLUE STAIN
K842086 · JTO
Difco Laboratories, Inc.
Microbiology · 40d
Cleared Jul 03, 1984
LYFO-DISK MICROORGANISMS
K842129 · JTR
Micro-Bio-Logics
Microbiology · 35d
Cleared Jul 02, 1984
VENTRESCREEN STREP A TEST
K842239 · GWC
Ventrex Laboratories, Inc.
Microbiology · 27d
Cleared Jul 02, 1984
PATHO DX LATEX AGGLUTINATION STREP A
K842383 · GTZ
Diagnostic Products Corp.
Microbiology · 14d
Cleared Jul 02, 1984
BIOTIS N.Y.C. CARBOHYDRATE FERMENTA-
K842400
Otisville Biotech, Inc.
Microbiology · 13d
Cleared Jul 02, 1984
BIOTIS LD-PRESUMPTO QUADRANT PLATE
K842424 · JSE
Otisville Biotech, Inc.
Microbiology · 12d
Cleared Jul 02, 1984
RIM STREP KIT
K842451 · JSE
Austin Biological Laboratories
Microbiology · 10d
Cleared Jun 27, 1984
IMR-90-DIPLOID-HUMAN FETAL LUNG CELL
K841998 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 42d
Cleared Jun 26, 1984
ZINC DUST SUSPENSION
K842299 · JSF
Irvine Diagnostic Services
Microbiology · 15d
Cleared Jun 25, 1984
ORTHO VARICELLA-ZOSTER VIRUS IDENT.
K841526 · GQX
Ortho Diagnostic Systems, Inc.
Microbiology · 74d
Cleared Jun 25, 1984
HL-1, DEFINED SERUM FREE MEDIA
K841993 · KIT
Ventrex Laboratories, Inc.
Microbiology · 41d
Cleared Jun 25, 1984
OXIDASE TEST STRIPS-OXIDASESURE
K842298 · JSF
Irvine Diagnostic Services
Microbiology · 14d
Cleared Jun 22, 1984
BGM CELL CULTURE AFRICAN GREEN MONKEY
K841999 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 37d
Cleared Jun 22, 1984
PRIMARY RABBITT KIDNEY CELL CULTURE
K842000 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 37d
Cleared Jun 22, 1984
SPOT TEST NINHYDRIN REAGENTS
K842290 · JSF
Difco Laboratories, Inc.
Microbiology · 11d
Cleared Jun 22, 1984
SPOT TEST CATALASE TEST
K842291 · JSF
Difco Laboratories, Inc.
Microbiology · 11d
Cleared Jun 22, 1984
ARGINIE BROTH
K842297 · JSF
Remel Co.
Microbiology · 11d
Cleared Jun 22, 1984
ONPG DISKS
K842300 · JSF
Irvine Diagnostic Services
Microbiology · 11d
Cleared Jun 19, 1984
MICROTRAKSPECIMAN ID TYPING TEST CONTR
K841191 · GQN
Syva Co.
Microbiology · 90d
Cleared Jun 19, 1984
RIM H2S
K842098 · JSF
Austin Biological Laboratories
Microbiology · 25d
Cleared Jun 19, 1984
AS LATEX PLUS
K842256 · GTQ
Biokit USA, Inc.
Microbiology · 12d
Cleared Jun 07, 1984
TRANSPORTER VIRAL TRANSPORT MEDIUM
K840744 · KIT
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 105d