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
3193–3216 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 21, 1993
SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA
K923892 · JSO
Smith River Biologicals
Microbiology · 321d
Cleared Jun 21, 1993
VIDAS TOXO COMPETITION (TXC) ASSAY
K931334 · LGD
Biomerieux Vitek, Inc.
Microbiology · 97d
Cleared Jun 18, 1993
AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA
K931151 · MLA
Microprobe Corp.
Microbiology · 102d
Cleared Jun 15, 1993
AMPLICOR CHLAMYDIA TRACHOMATIS TEST
K922906 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 363d
Cleared Jun 15, 1993
BION MUMPS-G ANTIBODY TEST SYSTEM
K926066 · CAR
Bion Ent., Ltd.
Microbiology · 196d
Cleared Jun 15, 1993
BECKMAN ANTI-STREPTOLYSIN O KIT
K926236 · GTQ
Beckman Instruments, Inc.
Microbiology · 186d
Cleared Jun 15, 1993
AFFIRM VPIII MICROBIAL IDENTIFICATION TEST
K931374 · MLA
Microprobe Corp.
Microbiology · 89d
Cleared Jun 15, 1993
ZINC PVA
K931383 · LIO
Remel Co.
Microbiology · 89d
Cleared Jun 15, 1993
PARA-PAK PLUS
K931770 · LIO
Meridian Diagnostics, Inc.
Microbiology · 67d
Cleared Jun 15, 1993
REMEL LORACARBEF 30 MCG SUSCEPTIBILITY DISK
K931799 · JTN
Remel Co.
Microbiology · 64d
Cleared Jun 15, 1993
NINHYDRIN REAGENT
K931862 · JTO
Hardy Diagnostics
Microbiology · 62d
Cleared Jun 02, 1993
REMEL CEFPODOXIME 10 MCG SUSCEPTIBILITY DISK
K931289 · JTN
Remel Co.
Microbiology · 82d
Cleared May 20, 1993
REMEL CEFMETAZOLE 30 MCG SUSCEPTIBILITY DISK
K931290 · JTN
Remel Co.
Microbiology · 69d
Cleared May 18, 1993
BBL CRYSTAL MRSA ID SYSTEM
K926294 · JWY
Becton Dickinson Microbiology Systems
Microbiology · 155d
Cleared May 13, 1993
PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION
K931147 · MHI
Alexon, Inc.
Microbiology · 69d
Cleared May 12, 1993
OXYSTRIP
K930693 · JTO
Hardy Diagnostics
Microbiology · 91d
Cleared May 12, 1993
PASCO MIC AND MIC/ID PANELS
K931069 · JWY
Pasco Laboratories, Inc.
Microbiology · 71d
Cleared May 12, 1993
CATALASE REAGENT
K931414 · JTO
Hardy Diagnostics
Microbiology · 90d
Cleared May 11, 1993
VIDAS TOXO IG6 ASSAY (TX6)
K922737 · LGD
Biomerieux Vitek, Inc.
Microbiology · 337d
Cleared May 11, 1993
BACTIDROP(TM) MUCAP
K930878 · JTO
Remel Co.
Microbiology · 81d
Cleared May 11, 1993
FERRIC CHLORID REAGENT, 10%
K931413 · JTO
Hardy Diagnostics
Microbiology · 89d
Cleared May 11, 1993
BILE SPOT REAGENT
K931530 · JTN
Hardy Diagnostics
Microbiology · 89d
Cleared Apr 27, 1993
DISPENS-O-DISC CLARITHROMYCIN 15 MG.
K930911 · JTN
Difco Laboratories, Inc.
Microbiology · 64d
Cleared Apr 27, 1993
DISPENS-O-DISC CEFPODOXIME 10 MCG.
K930946 · JTN
Difco Laboratories, Inc.
Microbiology · 63d