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
169–192 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 25, 2025
cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
K243406 · QOF
Roche Molecular Systems, Inc.
Microbiology · 175d
Cleared Apr 25, 2025
cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
K243400 · QOF
Roche Molecular Systems, Inc.
Microbiology · 176d
Cleared Apr 22, 2025
BD CTGCTV2
K243343 · QEP
Bd Integrated Diagnostic...
Microbiology · 179d
Cleared Apr 18, 2025
LIAISON PLEX Gram-Negative Blood Culture Assay
K243013 · PEN
Luminex Corporation
Microbiology · 203d
Cleared Apr 18, 2025
Acucy® Influenza A&B Test with the Acucy® 2 System
K241188 · PSZ
SEKISUI Diagnostics, LLC
Microbiology · 354d
Cleared Apr 15, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242658 · JWY
Thermo Fisher Scientific
Microbiology · 223d
Cleared Apr 11, 2025
cobas liat SARS-CoV-2 v2 nucleic acid test
K243346 · QWR
Roche Molecular Systems, Inc.
Microbiology · 165d
Cleared Apr 04, 2025
AllTest Viral Transport Medium
K242576 · JSM
Hangzhou AllTest Biotech Co., Ltd.
Microbiology · 218d
Cleared Mar 28, 2025
PBC Separator with Selux AST System
K244044 · QZX
Selux Diagnostics, Inc.
Microbiology · 88d
Cleared Mar 28, 2025
Access Toxo IgG
K242022 · LGD
Beckman Coulter, Inc.
Microbiology · 260d
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