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
2305–2328 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN...
K984133 · LLM
Zeus Scientific, Inc.
Microbiology · 54d
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME...
K984139 · LFZ
Zeus Scientific, Inc.
Microbiology · 54d
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
K984153 · LJZ
Zeus Scientific, Inc.
Microbiology · 53d
Cleared Jan 05, 1999
SYSTEM U3 FOR NITROFURANTOIN
K983565 · JWY
Ab Biodisk
Microbiology · 84d
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