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
2281–2304 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 30, 1998
SYSTEM U3 FOR TETRACYCLINE
K983571 · JWY
Ab Biodisk
Microbiology · 78d
Cleared Dec 23, 1998
SYSTEM U3 FOR NORFLOXACIN
K983486 · JWY
Ab Biodisk
Microbiology · 79d
Cleared Dec 22, 1998
LIGHT DIAGNOSTICS RABIES DFA REAGENT
K972975 · GOI
Light Diagnostics
Microbiology · 498d
Cleared Dec 18, 1998
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN
K983306 · LTT
Accumed Intl., Inc.
Microbiology · 88d
Cleared Dec 17, 1998
MODIFICATION TO: PREMIER PLATINUM HPSA
K983255 · LYR
Meridian Diagnostics, Inc.
Microbiology · 93d
Cleared Dec 17, 1998
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN
K983310 · JTT
Accumed Intl., Inc.
Microbiology · 87d
Cleared Dec 16, 1998
IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K983605 · LSR
Columbia Bioscience, Inc.
Microbiology · 63d
Cleared Dec 16, 1998
IS BORRELIA BURGDORFERI IGM TEST SYSTEM
K983606 · LSR
Columbia Bioscience, Inc.
Microbiology · 63d
Cleared Dec 15, 1998
ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973718 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 442d
Cleared Dec 14, 1998
BARTELS CINAKIT CMV ANTIGENEMIA
K982311 · GQH
Intracel Corp.
Microbiology · 166d
Cleared Dec 14, 1998
SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
K983309 · LTT
Accumed Intl., Inc.
Microbiology · 84d
Cleared Dec 14, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME...
K983803 · LFZ
Zeus Scientific, Inc.
Microbiology · 47d
Cleared Dec 11, 1998
IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500...
K982078 · LFX
Diagnostic Products Corp.
Microbiology · 179d
Cleared Dec 11, 1998
SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
K983599 · HHT
Andwin Scientific
Microbiology · 58d
Cleared Dec 11, 1998
MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K983718 · JTN
Oxoid , Ltd.
Microbiology · 51d
Cleared Dec 10, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN...
K983801 · LSE
Zeus Scientific, Inc.
Microbiology · 43d
Cleared Dec 08, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN...
K983804 · LSE
Zeus Scientific, Inc.
Microbiology · 41d
Cleared Dec 03, 1998
PREMIER CRYPTOSPORIDIUM
K982764 · MHJ
Meridian Diagnostics, Inc.
Microbiology · 119d
Cleared Nov 30, 1998
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)
K983244 · JTW
Trek Diagnostic Systems, Inc.
Microbiology · 75d
Cleared Nov 25, 1998
AB FLU OIA
K981651 · PSZ
Biostar, Inc.
Microbiology · 198d
Cleared Nov 25, 1998
MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY
K982027 · LFZ
DiaSorin, Inc.
Microbiology · 176d
Cleared Nov 25, 1998
EBNA-1 IGM ELISA TEST SYSTEM
K982348 · LSE
Columbia Bioscience, Inc.
Microbiology · 142d
Cleared Nov 25, 1998
EA-D IGM ELISA TEST SYSTEM
K982350 · LSE
Columbia Bioscience, Inc.
Microbiology · 142d
Cleared Nov 25, 1998
VCA IGM ELISA TEST SYSTEM
K982352 · LSE
Columbia Bioscience, Inc.
Microbiology · 142d