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
865–888 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 25, 2016
Solana Strep Complete Assay
K162274 · PGX
Quidel Corporation
Microbiology · 74d
Cleared Oct 25, 2016
chromID MRSA
K162076 · JSO
bioMerieux, Inc.
Microbiology · 90d
Cleared Oct 13, 2016
ADVIA Centaur HAV IgM Assay
K161964 · LOL
Siemens Healthcare Diagnostics, Inc.
Microbiology · 87d
Not Cleared Oct 06, 2016
APAS Compact with Urine Analysis Module
DEN150059 · PPU
Clever Culture Systems AG
Microbiology · 287d
Cleared Oct 03, 2016
FilmArray Respiratory Panel EZ (RP EZ)
K152579 · OCC
Biofire Diagnostics, LLC
Microbiology · 389d
Cleared Oct 01, 2016
SeraQuest Herpes Type 1 Specific IgG
K162276 · MXJ
Quest International, Inc.
Microbiology · 50d
Cleared Sep 27, 2016
Solana Influenza A+B Assay
K161814 · OCC
Quidel Corporation
Microbiology · 88d
Cleared Sep 06, 2016
BD MAX CT/GC/TV, BD MAX INSTRUMENT
K151589 · OUY
Becton, Dickinson and Company
Microbiology · 452d
Cleared Sep 02, 2016
FilmArray RP EZ Control Panel M265
K161573 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 87d
Cleared Aug 29, 2016
Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I,...
K161619 · OUY
Cepheid
Microbiology · 77d
Cleared Aug 25, 2016
Anti-Borrelia burgdorferi US Westernblot (IgG)
K161513 · LSR
Euroimmun US
Microbiology · 84d
Cleared Aug 25, 2016
LIAISON HAV IgM, LIAISON Control HAV IgM
K160650 · LOL
DiaSorin, Inc.
Microbiology · 170d
Cleared Aug 18, 2016
Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit
K161375 · OCC
Alere Scarborough, Inc.
Microbiology · 92d
Cleared CT Aug 15, 2016
Solana Trichomonas Assay
K161182 · OUY
Quidel Corporation
Microbiology · 110d
Cleared Aug 12, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgM)
K153308 · NOP
Euroimmun Us, Inc.
Microbiology · 269d
Cleared Aug 10, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgG)
K153303 · NOP
Euroimmun Us, Inc.
Microbiology · 268d
Cleared Aug 08, 2016
BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a...
K161306 · MDB
Becton Dickinson
Microbiology · 90d
Cleared CT Aug 02, 2016
ARIES® Flu A/B & RSV Assay
K161220 · OCC
Luminex Corporation
Microbiology · 95d
Cleared Jul 29, 2016
Puritan Opti-Tranz Cary-Blair Collection and Transport System
K160082 · JSM
Puritan Medical Products, LLC
Microbiology · 196d
Cleared Jul 28, 2016
Elecsys Syphilis
K160910 · LIP
Roche Diagnostics
Microbiology · 118d
Cleared Jul 25, 2016
cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
K153544 · OCC
Iquum, Inc.
Microbiology · 227d
Cleared Jul 22, 2016
LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
K161139 · LYR
DiaSorin, Inc.
Microbiology · 91d
Cleared Jul 20, 2016
VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
K161227 · LON
bioMerieux, Inc.
Microbiology · 79d
Cleared Jul 12, 2016
Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL
K161175 · JWY
Liofilchem S. R. L.
Microbiology · 77d