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
433–456 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 03, 2021
BD Kiestra IdentifA
K191964 · QQV
Becton, Dickinson and Company
Microbiology · 834d
Not Cleared Nov 03, 2021
OMNIgene GUT Dx
DEN200040 · QPO
DNA Genotek, Inc.
Microbiology · 506d
Cleared Nov 01, 2021
BioFire COVID-19 Test 2
K211079 · QQX
Biofire Defense, LLC
Microbiology · 203d
Cleared Oct 28, 2021
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
K210287 · LON
bioMerieux, Inc.
Microbiology · 268d
Cleared Oct 28, 2021
APAS Independence with IC Chromogenic MRSA BD Analysis Module
K200839 · QQY
Clever Culture Systems
Microbiology · 576d
Cleared Oct 27, 2021
Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
K210873 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 217d
Cleared Oct 20, 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System
K212427 · OZN
Roche Molecular Systems, Inc.
Microbiology · 77d
Cleared Oct 20, 2021
MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
K211672 · JWY
Liofilchem S. R. L.
Microbiology · 141d
Cleared Oct 20, 2021
InTray GC
K210511 · JTY
Biomed Diagnostics Incorporated
Microbiology · 239d
Cleared Oct 18, 2021
BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit
K201017 · PQA
Geneohm Sciences Canada, Inc. (Bd...
Microbiology · 549d
Cleared Sep 30, 2021
Acuitas AMR Gene Panel
K191288 · PMY
Opgen, Inc.
Microbiology · 871d
Cleared Sep 22, 2021
FilmArray Pneumonia Panel
K212727 · QDP
Biofire Diagnostics, LLC
Microbiology · 26d
Cleared Sep 20, 2021
Disposable Sampler Inactivated Transport Media, Nest ITM
K210440 · QBD
Wuxi Nest Biotechnology Co., Ltd.
Microbiology · 220d
Cleared Sep 14, 2021
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
K202396 · LON
bioMerieux, Inc.
Microbiology · 389d
Cleared Sep 09, 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System
K210385 · OZN
Roche Molecular Systems, Inc.
Microbiology · 212d
Cleared Sep 01, 2021
MeMed BV
K210254 · QPS
MeMed Diagnostics, Ltd.
Microbiology · 215d
Cleared Aug 30, 2021
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
K211630 · LON
bioMerieux, Inc.
Microbiology · 95d
Cleared Aug 26, 2021
Visby Medical Sexual Health
K200748 · QEP
Visby Medical
Microbiology · 521d
Cleared Aug 11, 2021
Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha...
K212204 · QGN
Cd Diagnostics, Inc.
Microbiology · 27d
Cleared Jul 30, 2021
Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
K203700 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 224d
Cleared Jul 23, 2021
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or...
K202612 · JWY
Thermo Fisher Scientific
Microbiology · 317d
Cleared Jul 20, 2021
Elecsys Syphilis
K211302 · LIP
Roche Diagnostics
Microbiology · 82d
Cleared Jul 09, 2021
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
K201675 · LON
bioMerieux, Inc.
Microbiology · 385d
Cleared Jul 08, 2021
SensiTox C. difficile Toxin Test
K193490 · LLH
First Light Diagnostics, Inc.
Microbiology · 569d