FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
841–864 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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 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 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
Cleared Jul 05, 2016
Lumipulse G TP-N Immunoreaction Cartridge Set
K153145 · LIP
Fujirebio Diagnostics,Inc.
Microbiology · 249d
Cleared Jun 30, 2016
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A...
K161556 · OZE
Centers For Disease Control and...
Microbiology · 24d
Cleared Jun 30, 2016
LIAISON CMV IgM Serum Control Set
K161526 · JJX
DiaSorin, Inc.
Microbiology · 28d
Cleared Jun 30, 2016
LIAISON EBV IgM Serum Control Set
K161522 · JJX
DiaSorin, Inc.
Microbiology · 28d