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
937–960 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 18, 2015
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
K143651 · PGX
Focus Diagnostics, Inc.
Microbiology · 85d
Cleared Mar 17, 2015
AmpliVue Trichomonas Assay
K143329 · OUY
Quidel Corporation
Microbiology · 117d
Cleared Mar 11, 2015
LIAISON VZV IgG, LIAISON Control VZV IgG
K150375 · LFY
DiaSorin, Inc.
Microbiology · 26d
Cleared Mar 05, 2015
The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)
K143526 · JWY
Thermo Fisher Scientific
Microbiology · 83d
Cleared Mar 02, 2015
Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml)
K142338 · JWY
Thermo Fisher Scientific
Microbiology · 193d
Cleared Feb 25, 2015
MCC Para-Fix CARY BLAIR MEDIUM
K141506 · JSM
Medical Chemical Corporation
Microbiology · 264d
Cleared Feb 19, 2015
Sensititre Susceptibility Plates
K143381 · JWY
Thermo Fisher Scientific
Microbiology · 86d
Cleared Feb 19, 2015
FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0
K143005 · PCH
Biofire Diagnostics, LLC
Microbiology · 122d
Cleared Feb 17, 2015
FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System
K143080 · OCC
Biofire Diagnostics, LLC
Microbiology · 113d
Cleared Feb 13, 2015
SEEGENE ANYPLEX II HSV-1/2 ASSAY
K142156 · OQO
Seegene
Microbiology · 191d
Cleared Feb 12, 2015
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert...
K143302 · PEU
Cepheid
Microbiology · 87d
Cleared Jan 30, 2015
FilmArray 2.0 System
K143178 · NSU
Biofire Diagnostics, LLC
Microbiology · 87d
Cleared Jan 30, 2015
FilmArray Blood Culture Identification (BCID) Panel for use with the...
K143171 · PEN
Biofire Diagnostics, LLC
Microbiology · 87d
Cleared Jan 09, 2015
Puritan OptiTranz Liquid Stuart Collection and Transport System
K142366 · JSM
Puritan Medical Products, LLC
Microbiology · 137d
Cleared Dec 23, 2014
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K142151 · JWY
Thermo Fisher Scientific
Microbiology · 139d
Cleared Dec 19, 2014
artus HSV-1/2 QS-RGQ MDx Kit
K142738 · OQO
Qiagen
Microbiology · 87d
Cleared Dec 17, 2014
cobas MRSA/SA Test
K142721 · NQX
Roche Molecular Systems, Inc.
Microbiology · 85d
Cleared Dec 16, 2014
SOFIA (R) STREP A+ FIA
K141775 · GTY
Quidel Corporation
Microbiology · 168d
Cleared Dec 10, 2014
AmpliVue Bordetella Assay
K143206 · OZZ
Quidel Corporation
Microbiology · 33d
Cleared Dec 10, 2014
BD BACTEC PLUS ANAEROBIC/F (PLASTIC)
K141810 · MDB
Becton, Dickinson and Company
Microbiology · 156d
Cleared Dec 05, 2014
ADVIA Centaur HAV total assay
K142758 · LOL
Siemens Healthcare Diagnostics, Inc.
Microbiology · 71d
Cleared Dec 05, 2014
Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack
K142365 · OCC
Focus Diagnostics
Microbiology · 102d
Cleared Nov 26, 2014
Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert...
K142501 · PCH
Cepheid
Microbiology · 82d
Cleared Nov 22, 2014
XPERT FLU/RSV XC ASSAY
K142045 · OCC
Cepheid
Microbiology · 117d