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
25–48 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 30, 2026
AllTest Strep A Rapid Test
K260342 · GTY
Hangzhou AllTest Biotech Co., Ltd.
Microbiology · 87d
Cleared Apr 28, 2026
Anti-HCV Next
K252424 · MZO
Abbott Laboratories
Microbiology · 270d
Cleared Apr 21, 2026
ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
K260447 · JWY
Biom?rieux SA
Microbiology · 69d
Cleared Apr 17, 2026
MTS Gepotidacin 0.016-256 µg/mL
K260696 · JWY
Liofilchem S. R. L.
Microbiology · 45d
Cleared Apr 15, 2026
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
K260282 · LON
bioMerieux, Inc.
Microbiology · 76d
Cleared Apr 15, 2026
ASTar BC G- Kit
K253573 · SAN
Q-Linea AB
Microbiology · 149d
Cleared Apr 13, 2026
Heal-Check Rapid COVID-19 Antigen Self-Test
K260095 · QYT
Healgen Scientific, LLC
Microbiology · 90d
Cleared Apr 13, 2026
Elecsys Anti-SARS-CoV-2 S
K252280 · QVP
Roche Diagnostics
Microbiology · 265d
Cleared Apr 07, 2026
Elecsys Anti-HBc IgM
K260049 · SEI
Roche Diagnostics
Microbiology · 90d
Cleared Apr 07, 2026
Elecsys Anti-HAV IgM
K260048 · LOL
Roche Diagnostics
Microbiology · 90d
Cleared Apr 07, 2026
Elecsys Anti-HBc II
K260046 · SEI
Roche Diagnostics
Microbiology · 90d
Cleared Apr 02, 2026
Onclarity™ Self-Collection Kit
K260184 · SEP
Becton, Dickinson and Company
Microbiology · 71d
Cleared Mar 27, 2026
MDx-Chex for BCP
K260041 · PMN
Streck, LLC
Microbiology · 80d
Cleared Mar 26, 2026
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
K260281 · LON
BIOMERIEUX
Microbiology · 56d
Cleared Mar 24, 2026
FebriDx Bacterial/Non-bacterial Assay
K260787 · QXA
Lumos Diagnostics, Inc.
Microbiology · 14d
Cleared Mar 23, 2026
MDx-Chex for BCN
K254166 · PMN
Streck
Microbiology · 90d
Cleared Mar 17, 2026
MDx-Chex for BCY
K254167 · PMN
Streck, LLC
Microbiology · 84d
Cleared Mar 13, 2026
Access anti-HBc IgM
K254059 · SEI
Beckman Coulter, Inc.
Microbiology · 86d
Cleared Mar 13, 2026
GenBody COVID-19 Ag Home Test
K251916 · QYT
Genbody.Inc.
Microbiology · 263d
Cleared Mar 09, 2026
QIAstat-Dx Gastrointestinal Panel 2
K254032 · PCH
QIAGEN GmbH
Microbiology · 83d
Cleared Feb 20, 2026
Xpert Hemorrhagic Fever
K253653
Cepheid
Microbiology · 92d
Cleared Feb 19, 2026
Access anti-HBc Total
K253687 · SEI
Beckman Coulter, Inc.
Microbiology · 90d
Cleared Feb 13, 2026
VELO Respiratory Test
K251742 · QOF
Lex Diagnostics Limited
Microbiology · 252d
Cleared Jan 30, 2026
Clungene RSV Antigen Rapid Test
K253318 · GQG
Hangzhou Clongene Biotech Co., Ltd.
Microbiology · 122d