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
505–528 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 13, 2020
Curian HpSA, Curian Analyzer
K192817 · LYR
Meridian Bioscience, Inc.
Microbiology · 164d
Cleared Mar 12, 2020
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K193538 · JWY
Thermo Fisher Scientific
Microbiology · 83d
Cleared Mar 10, 2020
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B...
K200370 · OZE
Centers For Disease Control and...
Microbiology · 25d
Cleared Mar 09, 2020
Elecsys BRAHMS PCT
K192815 · PRI
Roche Diagnostics
Microbiology · 160d
Cleared Mar 05, 2020
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
K191184 · MJH
Ssi Diagnostica A/S
Microbiology · 307d
Cleared Mar 03, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx)...
K193358 · LTT
Beckman Coulter, Inc.
Microbiology · 90d
Cleared Mar 02, 2020
LIAISON Anti-HAV Assay
K193532 · LOL
DiaSorin, Inc.
Microbiology · 73d
Cleared Feb 25, 2020
VITROS BRAHMS PCT Reagent Pack and Calibrators
K200236 · PMT
Ortho-Clinical Diagnostics
Microbiology · 26d
Cleared Feb 18, 2020
CareStart Flu A&B Plus
K191514 · PSZ
Access Bio, Inc.
Microbiology · 256d
Cleared Feb 14, 2020
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)
K193567 · LON
bioMerieux, Inc.
Microbiology · 53d
Cleared Feb 10, 2020
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas...
K200065 · OCC
Roche Molecular Systems, Inc.
Microbiology · 28d
Cleared Feb 06, 2020
BreathID Smart System
K193610 · MSQ
Exalenz Bioscience , Ltd.
Microbiology · 42d
Cleared Jan 29, 2020
LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
K193051 · LSR
DiaSorin, Inc.
Microbiology · 89d
Cleared Jan 23, 2020
HardyDisk AST Cefiderocol 30ug (FDC30)
K193504 · JTN
Hardy Diagnostics
Microbiology · 36d
Cleared Jan 08, 2020
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K193024 · JWY
Thermo Fisher Scientific
Microbiology · 70d
Cleared Dec 23, 2019
BioCode Respiratory Pathogen Panel (RPP)
K192485 · OCC
Applied BioCode, Inc.
Microbiology · 104d
Cleared Dec 20, 2019
Unyvero LRT BAL Application
K191967 · QBH
Curetis GmbH
Microbiology · 150d
Cleared Dec 11, 2019
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files,...
K193167 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 26d
Not Cleared Dec 05, 2019
cobas vivoDx MRSA
DEN190016 · QIV
Roche Molecular Systems, Inc.
Microbiology · 261d
Not Cleared Dec 02, 2019
WOUNDCHEK Bacterial Status
DEN180014 · QFA
Alere Scarborough, Inc.
Microbiology · 619d
Cleared Nov 26, 2019
ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
K192738 · JWY
Biomerieux S.A.
Microbiology · 60d
Cleared Nov 26, 2019
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
K192376 · PGI
Diasorin Molecular, LLC
Microbiology · 88d
Cleared Nov 26, 2019
Access PCT, Access PCT Calibrators
K192271 · PTF
Beckman Coulter, Inc.
Microbiology · 96d
Cleared Nov 14, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer)...
K192355 · JWY
Beckman Coulter, Inc.
Microbiology · 77d