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
121–144 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 10, 2025
Elecsys Anti-SARS-CoV-2
K250768 · QVP
Roche Diagnostics
Microbiology · 89d
Cleared Jun 06, 2025
LIAISON PLEX Gram-Positive Blood Culture Assay
K243490 · PAM
Luminex Corporation
Microbiology · 206d
Cleared Jun 04, 2025
NG-Test® CTX-M MULTI
K243499 · PTJ
Ng Biotech
Microbiology · 204d
Cleared May 30, 2025
OHC COVID-19 Antigen Self Test
K241313 · QYT
Osang, LLC
Microbiology · 386d
Cleared May 27, 2025
Puritan PurSafe Plus Collection and Transport System
K242820 · QBD
Puritan Medical Products, LLC
Microbiology · 251d
Cleared May 22, 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242659 · JWY
Thermo Fisher Scientific
Microbiology · 260d
Cleared May 19, 2025
BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4...
K250447 · LON
Becton, Dickinson and Company
Microbiology · 90d
Cleared May 15, 2025
HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
K250454 · JTN
Hardy Diagnostics
Microbiology · 86d
Cleared May 10, 2025
Flowflex Plus COVID-19 + Flu A/B Home Test
K250377 · SCA
ACON Laboratories, Inc.
Microbiology · 89d
Cleared May 09, 2025
DiaSys Procalcitonin FS
K242294 · PTF
Diasys Diagnostic Systems GmbH
Microbiology · 280d
Not Cleared May 09, 2025
Teal Wand
DEN240045 · SEP
Teal Health, Inc.
Microbiology · 255d
Cleared May 01, 2025
Xpert Xpress CoV-2/Flu/RSV plus
K250996 · QOF
Cepheid
Microbiology · 30d
Cleared May 01, 2025
Xpert Xpress CoV-2/Flu/RSV plus
K250995 · QOF
Cepheid
Microbiology · 30d
Cleared Apr 30, 2025
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
K250274 · JWY
Biomerieux S.A.
Microbiology · 90d
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