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
2257–2280 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 26, 1999
HSV 1+2 IGG ELISA TEST
K983541 · LGC
Gull Laboratories, Inc.
Microbiology · 140d
Cleared Feb 18, 1999
SYSTEM U3
K983890 · JWY
Ab Biodisk
Microbiology · 108d
Cleared Feb 18, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED...
K984544 · LYR
Enteric Products, Inc.
Microbiology · 58d
Cleared Feb 16, 1999
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM
K981829 · GNP
Diamedix Corp.
Microbiology · 270d
Cleared Feb 16, 1999
IS EBV-EA-D IGG ELISA TEST SYSTEM
K981831 · GNP
Diamedix Corp.
Microbiology · 270d
Cleared Feb 16, 1999
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K984489 · JWY
Accumed Intl., Inc.
Microbiology · 61d
Cleared Feb 12, 1999
PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY
K981913 · LSR
Chembio Diagnostic Systems, Inc.
Microbiology · 256d
Cleared Feb 11, 1999
UNI-GOLD STREP A TEST KIT
K982373 · GTY
Trinity Biotech, Plc
Microbiology · 219d
Cleared Feb 09, 1999
SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID
K984144 · JWY
Ab Biodisk
Microbiology · 83d
Cleared Feb 08, 1999
SYSTEM U3 FOR AMPICILLIN
K984087 · JWY
Ab Biodisk
Microbiology · 84d
Cleared Jan 28, 1999
IS-RUBELLA IGG TEST SYSTEM
K981729 · LFX
Diamedix Corp.
Microbiology · 258d
Cleared Jan 22, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM
K984181 · LFY
Zeus Scientific, Inc.
Microbiology · 60d
Cleared Jan 22, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN...
K984317 · LGD
Zeus Scientific, Inc.
Microbiology · 50d
Cleared Jan 19, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM
K984170 · LGD
Zeus Scientific, Inc.
Microbiology · 60d
Cleared Jan 13, 1999
SERAQUEST CMV IGM
K982485 · LFZ
Quest Intl., Inc.
Microbiology · 180d
Cleared Jan 13, 1999
MB/BACT BLOOD CULTURE BOTTLE
K983772 · MDB
Organon Teknika Corp.
Microbiology · 79d
Cleared Jan 13, 1999
NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K984036 · JTN
Oxoid , Ltd.
Microbiology · 62d
Cleared Jan 11, 1999
GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
K983399 · MHI
Genzyme Diagnostics
Microbiology · 105d
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST...
K984123 · LHL
Zeus Scientific, Inc.
Microbiology · 54d
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN...
K984126 · MCD
Zeus Scientific, Inc.
Microbiology · 54d
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