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
145–168 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Not Cleared Mar 28, 2025
Visby Medical Women's Sexual Health Test
DEN240020 · SEA
Visby Medical, Inc.
Microbiology · 319d
Cleared Mar 24, 2025
Alinity m BKV
K241921 · QMI
Abbott Molecular, Inc.
Microbiology · 266d
Cleared Mar 21, 2025
IntelliSep Test (CV-ICG-048)
K250513 · QUT
Cytovale, Inc.
Microbiology · 28d
Cleared Mar 20, 2025
Revogene
K243922 · OOI
Meridian Bioscience, Inc.
Microbiology · 90d
Cleared Mar 14, 2025
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B...
K243931 · OZE
Centers For Disease Control and...
Microbiology · 84d
Cleared Mar 14, 2025
VITEK COMPACT PRO
K234012 · LON
bioMerieux, Inc.
Microbiology · 451d
Cleared Mar 12, 2025
BioFire Warrior Panel
K243822 · PRD
Biofire Defense, LLC
Microbiology · 90d
Cleared Mar 06, 2025
BD Phoenix™ Automated Microbiology System
K250344 · LON
Becton, Dickinson and Company
Microbiology · 28d
Cleared Feb 28, 2025
QIAstat-Dx GI Panel 2 Mini B
K250324 · PCH
QIAGEN GmbH
Microbiology · 23d
Cleared Feb 28, 2025
Xpert C. difficile/Epi
K243730 · OZN
Cepheid
Microbiology · 87d
Cleared Feb 27, 2025
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution...
K243738 · NGZ
Thermo Fisher Scientific
Microbiology · 85d
Cleared Feb 19, 2025
Visby Medical Respiratory Health Test
K242526 · QOF
Visby Medical, Inc.
Microbiology · 177d
Cleared Feb 14, 2025
Alinity m Resp-4-Plex
K241573 · QOF
Abbott Molecular, Inc.
Microbiology · 256d
Cleared Feb 13, 2025
Aptima SARS-CoV-2 Assay
K243396 · QQX
Hologic, Inc.
Microbiology · 105d
Cleared Feb 12, 2025
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG...
K243575 · MYF
Biokit, S.A.
Microbiology · 85d
Cleared Feb 11, 2025
BinaxNOW™ COVID-19 Antigen Self Test
K243518 · QYT
Abbott Diagnostics Scarborough, Inc.
Microbiology · 90d
Cleared Feb 11, 2025
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
K240867 · QQX
Roche Molecular Systems, Inc.
Microbiology · 319d
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K243201 · JWY
Thermo Fisher Scientific
Microbiology · 132d
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242905 · JWY
Thermo Fisher Scientific
Microbiology · 139d
Cleared Jan 30, 2025
simpli-COLLECT STI Test
K243410 · QYA
Abbott Molecular
Microbiology · 90d
Cleared Jan 30, 2025
MTS Ceftobiprole 0.002-32 µg/mL
K243202 · JWY
Liofilchem S. R. L.
Microbiology · 121d
Cleared Jan 29, 2025
CareSuperb™ COVID-19 Antigen Home Test
K241915 · QYT
Access Bio, Inc.
Microbiology · 212d
Cleared Jan 17, 2025
Aptima CMV Quant Assay
K243935 · PAB
Hologic, Inc.
Microbiology · 28d
Cleared Jan 17, 2025
cobas® liat CT/NG nucleic acid test
K240217 · QEP
Roche Molecular Systems, Inc.
Microbiology · 357d