Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
2353–2376 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 22, 1998
IMMUNODOT MONO-M TEST
K974244 · LSE
Genbio
Microbiology · 314d
Cleared Sep 22, 1998
BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
K980798 · LYR
Princeton BioMeditech Corp.
Microbiology · 204d
Cleared Sep 22, 1998
VTEC-RPLA SEIKEN
K981734 · GNA
Denka Seiken'S
Microbiology · 127d
Cleared Sep 21, 1998
DIAMEDIX IS-CMV IGG TEST SYSTEM
K981163 · LFZ
Diamedix Corp.
Microbiology · 174d
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