FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,061 results
1129–1152 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 26, 2012
ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
K113397 · LSR
Zeus Scientific, Inc.
Microbiology · 252d
Cleared Jul 26, 2012
ALERE PBP2A TEST
K121905 · MYI
Alere Scarborough, Inc.
Microbiology · 27d
Cleared Jul 25, 2012
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
K120625 · MXJ
Roche Diagnostics
Microbiology · 146d
Cleared Jul 13, 2012
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
K120413 · OCC
Focus Diagnostics, Inc.
Microbiology · 154d
Cleared Jul 05, 2012
BD MAX MRSA ASSAY, BD MAX INSTRUMENT
K120138 · NQX
Bd Diagnostics (Geneohm Sciences...
Microbiology · 170d
Cleared Jun 29, 2012
VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM
K113200 · LON
bioMerieux, Inc.
Microbiology · 242d
Cleared Jun 28, 2012
ARCHITECT HAVAB-G
K113704 · LOL
Abbott Laboratories
Microbiology · 195d
Not Cleared Jun 26, 2012
VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
DEN120014 · PAM
Nanosphere, Inc.
Microbiology · 11d
Cleared Jun 22, 2012
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
K120959 · MXJ
Bio-Rad Laboratories
Microbiology · 84d
Cleared Jun 08, 2012
TRANSPORT CULTURE MEDIUM DEVICE
K120846 · LIO
Puritan Medical Products, LLC
Microbiology · 80d
Cleared Jun 01, 2012
MRSA/SA ELITE MGB
K112937 · NQX
Elitech
Microbiology · 242d
Cleared Jun 01, 2012
BORRELIA BURGDORFERI IGM BLOT TEST
K113846 · LSR
Gold Standard Diagnostics
Microbiology · 155d
Cleared May 25, 2012
COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
K121039 · JTW
Copan Flock Technologies
Microbiology · 50d
Not Cleared May 24, 2012
CDC DENV-1-4 REAL TIME RT-PCT ASSAY
DEN120012 · OZB
Centers For Disease Control and...
Microbiology · 73d
Cleared May 18, 2012
XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
K120911 · OQW
Cepheid
Microbiology · 53d
Cleared May 15, 2012
FILMARRAY RP PANEL
K120267 · OCC
Idaho Technology, Inc.
Microbiology · 106d
Cleared May 03, 2012
APTIMA COMBO 2 ASSAY
K111409 · LSL
Gen-Probe, Inc.
Microbiology · 350d
Cleared May 01, 2012
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
K121044 · NJR
Meridian Bioscience, Inc.
Microbiology · 25d
Not Cleared Apr 30, 2012
PORTRAIT ANALYZER
DEN120013 · OMN
Great Basin Scientific
Microbiology · 59d
Cleared Apr 11, 2012
BORRELIA BURGDORFERI IGG BLOT TEST
K113847 · LSR
Gold Standard Diagnostics
Microbiology · 104d
Cleared Apr 04, 2012
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
K113433 · OMN
Focus Diagnostics, Inc.
Microbiology · 135d
Cleared Apr 03, 2012
STAPHYLOCOCCUS QUICKFISH BC
K113371 · NXX
Advandx, Inc.
Microbiology · 139d
Cleared Mar 30, 2012
KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT
K120563 · OUS
Microphage, Inc.
Microbiology · 35d
Cleared Mar 28, 2012
CRAG LATERAL FLOW ASSAY (LFA)
K112422 · GMD
Immuno-Mycologics, Inc.
Microbiology · 218d