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
73–96 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 22, 2025
QIAstat-Dx Gastrointestinal Panel 2
K252329 · PCH
QIAGEN GmbH
Microbiology · 89d
Cleared Oct 22, 2025
Flowflex Plus RSV + Flu A/B + COVID Home Test
K251749 · SCA
ACON Laboratories, Inc.
Microbiology · 138d
Cleared Oct 22, 2025
WELLlife COVID-19 Antigen Test Rx
K251289 · QVF
Guangzhou Wondfo Biotech Co., Ltd.
Microbiology · 180d
Cleared Oct 12, 2025
COVID-19 Detect Rapid Self -Test
K251595 · QYT
InBios International, Inc.
Microbiology · 138d
Cleared Oct 10, 2025
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated...
K250249 · GMQ
Gold Standard Diagnostics, LLC
Microbiology · 256d
Cleared Oct 02, 2025
MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
K252114 · JWY
Liofilchem S. R. L.
Microbiology · 87d
Cleared Oct 01, 2025
Visby Medical Men's Sexual Health Test
K251501 · QEP
Visby Medical, Inc.
Microbiology · 139d
Cleared Sep 30, 2025
Francisella tularensis Real-time PCR assay
K252072 · SGA
Centers For Disease Control and...
Microbiology · 91d
Cleared Sep 30, 2025
miDiagnostics HSV-1&2 CSF Test
K250050 · PGH
Midiagnostics NV
Microbiology · 263d
Cleared Sep 25, 2025
Alinity m HCV
K252102 · MZP
Abbott Molecular, Inc.
Microbiology · 84d
Cleared Sep 25, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K252062 · JWY
Thermo Fisher Scientific
Microbiology · 86d
Cleared Sep 25, 2025
Panther Fusion GI Expanded Bacterial Assay
K251993 · PCH
Hologic, Inc.
Microbiology · 90d
Cleared Sep 25, 2025
Panther Fusion GI Bacterial Assay
K251868 · PCH
Hologic
Microbiology · 99d
Cleared Sep 22, 2025
Babio® Virus Transport Kit (Non-inactivating)
K250205 · JSM
Jinan Babio Biotechnology Co., Ltd.
Microbiology · 241d
Cleared Sep 09, 2025
Access anti-HAV
K243846 · LOL
Beckman Coulter, Inc.
Microbiology · 267d
Cleared Sep 05, 2025
GenaCheck COVID-19 Rapid Self-Test
K251753 · QYT
Genabio Diagnostics, Inc.
Microbiology · 88d
Cleared Sep 05, 2025
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with...
K250575 · JWY
Thermo Fisher Scientific
Microbiology · 191d
Cleared Aug 28, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K252014 · JWY
Thermo Fisher Scientific
Microbiology · 62d
Cleared Aug 27, 2025
QIAstat-Dx Respiratory Panel Plus
K250080 · QOF
QIAGEN GmbH
Microbiology · 226d
Cleared Aug 22, 2025
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
K251604 · SCA
Access Bio, Inc.
Microbiology · 87d
Cleared Aug 21, 2025
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
K251579 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Aug 20, 2025
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
K251580 · JWY
Liofilchem S. R. L.
Microbiology · 89d
Cleared Aug 20, 2025
WELLlife Flu A&B Home Test
K251563 · SCA
Wondfo USA Co., Ltd.
Microbiology · 90d
Cleared Aug 20, 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64...
K243804 · LTT
Beckman Coulter, Inc.
Microbiology · 252d