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
73–96 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 14, 2025
Status™ COVID-19/Flu A&B
K251538 · SCA
Princeton BioMeditech Corp.
Microbiology · 179d
Cleared Nov 03, 2025
cobas HCV
K252484 · MZP
Roche Molecular Systems, Inc.
Microbiology · 88d
Cleared Nov 03, 2025
cobas CMV
K252481 · PAB
Roche Molecular Systems, Inc.
Microbiology · 88d
Cleared Oct 31, 2025
BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus...
K250358 · PCI
Becton, Dickinson and Company
Microbiology · 266d
Cleared Oct 30, 2025
Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450)
K252387 · QOF
Diasorin Molecular, LLC
Microbiology · 91d
Cleared Oct 27, 2025
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
K251875 · SAN
Affinity Biosensors, LLC
Microbiology · 131d
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