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
961–984 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 01, 2015
cobas HSV 1 and 2 Test
K150617 · OQO
Roche Molecular Systems, Inc.
Microbiology · 83d
Cleared May 29, 2015
Para-Fix C&S Medium
K150887 · JSM
Medical Chemical Corporation
Microbiology · 57d
Cleared May 20, 2015
cobas Cdiff Test
K142422 · OZN
Roche Molecular Systems, Inc.
Microbiology · 265d
Cleared May 04, 2015
EUROIMMUN LYME ELISA(IgG/IgM)
K142038 · LSR
Euroimmun US
Microbiology · 280d
Cleared Apr 21, 2015
Portrait GBS Assay
K143312 · NJR
Great Basin Corporation
Microbiology · 154d
Cleared Apr 16, 2015
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC
K143592 · NVQ
The Surgeon General, Department of...
Microbiology · 119d
Cleared Apr 10, 2015
COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
K142094 · JSM
Copan Italia Spa
Microbiology · 252d
Cleared Apr 01, 2015
Sensititre Susceptibility plates
K143288 · JWY
Thermo Fisher Scientific
Microbiology · 135d
Cleared Mar 31, 2015
ALERE I STREP A
K141757 · PGX
Alere Scarborough, Inc.
Microbiology · 274d
Cleared CT Mar 27, 2015
MALDI Biotyper CA System
K142677 · PEX
Bruker Daltonics, Inc.
Microbiology · 189d
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 CT 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