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
2329–2352 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 17, 1998
ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS...
K973448 · LGD
Beckman Instruments, Inc.
Microbiology · 371d
Cleared Sep 09, 1998
CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982517 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982519 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982520 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982523 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982524 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982526 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982528 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Sep 09, 1998
OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982669 · JTN
Oxoid , Ltd.
Microbiology · 40d
Cleared Sep 03, 1998
SYSTEM U3 FOR CIPROFLOXACIN
K981639 · JWY
Ab Biodisk
Microbiology · 118d
Cleared Sep 03, 1998
MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
K982709 · MHJ
Alexon - Trend, Inc.
Microbiology · 30d
Cleared Aug 31, 1998
HEMOSITE TEST SYSTEM
K973649 · KHG
Gds Technology, LLC
Microbiology · 340d
Cleared Aug 25, 1998
ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES
K982429 · PSZ
Zymetx, Inc.
Microbiology · 43d
Cleared Aug 21, 1998
ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
K981120 · LSE
Zeus Scientific, Inc.
Microbiology · 147d
Cleared Aug 21, 1998
IS-TOXOPLASMA IGG TEST SYSTEM
K981498 · LGD
Diamedix Corp.
Microbiology · 116d
Cleared Aug 21, 1998
BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG...
K982238 · MJH
Binax, Inc.
Microbiology · 57d
Cleared Aug 18, 1998
MB/BACT BLOOD CULTURE BOTTLE
K982263 · MDB
Organon Teknika Corp.
Microbiology · 50d
Cleared Aug 10, 1998
IMMUNOWELL VCA IGM TEST
K973939 · LJN
Genbio
Microbiology · 299d
Cleared Aug 10, 1998
IMMUNOWELL EBV VCA IGG TEST
K973940 · LSE
Genbio
Microbiology · 299d
Cleared Aug 10, 1998
IMMUNOWELL EBNA IGG TEST
K973941 · LLM
Genbio
Microbiology · 299d
Cleared Aug 06, 1998
TOXOGEN
K981263 · GMM
Instrumentation Laboratory CO
Microbiology · 121d
Cleared Aug 05, 1998
STAT-SIMPLE PYLORI
K980782 · LYR
Saliva Diagnostic Systems, Inc.
Microbiology · 156d
Cleared Jul 30, 1998
DIPSTREAK
K974428 · JSI
Novamed , Ltd.
Microbiology · 248d
Cleared Jul 30, 1998
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
K980821 · LYR
Zeus Scientific, Inc.
Microbiology · 149d