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
2281–2304 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 09, 1999
GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K984608 · JTN
Oxoid , Ltd.
Microbiology · 71d
Cleared Mar 05, 1999
BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
K980351 · LSR
Boston Biomedica, Inc.
Microbiology · 400d
Cleared Mar 04, 1999
EBV-VCA IGG ELISA TEST SYSTEM
K981812 · LSE
Diamedix Corp.
Microbiology · 286d
Cleared Mar 04, 1999
VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES
K984596 · GNR
Zymetx, Inc.
Microbiology · 66d
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