Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Microbiology ×
7,095 results
97–120 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Nov 20, 2025
cobas liat Bordetella panel nucleic acid test
K243753 · OZZ
Roche Molecular Systems, Inc.
Microbiology · 350d
Cleared Nov 19, 2025
IntelliSep Test
K250912 · QUT
Cytovale, Inc.
Microbiology · 237d
Cleared Nov 17, 2025
Access Rubella IgG
K250588 · LFX
Beckman Coulter, Inc.
Microbiology · 263d
Cleared Nov 14, 2025
Lyme-ID IgG Test
K252627 · LSR
Inanovate, Inc.
Microbiology · 86d
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