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
49–72 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 04, 2026
LIAISON Murex HBsAg Qual
K260770 · LOM
DiaSorin, Inc.
Microbiology · 87d
Cleared Jun 01, 2026
CorDx Tyfast COVID-19 Ag Rapid Test Rx
K253882 · QVF
CorDx, Inc.
Microbiology · 179d
Cleared May 28, 2026
BD BACTEC FXI Culture System
K260213 · MDB
Bd Diagnostic Systems
Microbiology · 125d
Cleared May 27, 2026
Visby Medical Flu and COVID-19 Test
K253971 · SIA
Visby Medical, Inc.
Microbiology · 167d
Cleared May 19, 2026
FilmArray TF Control Panel M527
K260577 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 88d
Cleared May 19, 2026
LIAISON PLEX Gastrointestinal Flex Assay
K253722 · PCH
Luminex Corporation
Microbiology · 176d
Cleared May 15, 2026
cobas liat CT/NG/MG nucleic acid test
K253759 · QEP
Roche Molecular Systems, Inc.
Microbiology · 171d
Cleared May 15, 2026
cobas liat CT/NG nucleic acid test
K253756 · QEP
Roche Molecular Systems, Inc.
Microbiology · 171d
Cleared May 11, 2026
HardyDisk AST Gepotidacin 10µg (GEP10)
K260842 · JTN
Hardy Diagnostics
Microbiology · 56d
Cleared May 01, 2026
BioCode® Respiratory Pathogen Panel (RPP)
K254139 · OCC
Applied BioCode, Inc.
Microbiology · 130d
Cleared Apr 30, 2026
AllTest Strep A Rapid Test
K260342 · GTY
Hangzhou AllTest Biotech Co., Ltd.
Microbiology · 87d
Cleared Apr 28, 2026
Anti-HCV Next
K252424 · MZO
Abbott Laboratories
Microbiology · 270d
Cleared Apr 21, 2026
ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
K260447 · JWY
Biom?rieux SA
Microbiology · 69d
Cleared Apr 17, 2026
MTS Gepotidacin 0.016-256 µg/mL
K260696 · JWY
Liofilchem S. R. L.
Microbiology · 45d
Cleared Apr 15, 2026
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
K260282 · LON
bioMerieux, Inc.
Microbiology · 76d
Cleared Apr 15, 2026
ASTar BC G- Kit
K253573 · SAN
Q-Linea AB
Microbiology · 149d
Cleared Apr 13, 2026
Heal-Check Rapid COVID-19 Antigen Self-Test
K260095 · QYT
Healgen Scientific, LLC
Microbiology · 90d
Cleared Apr 13, 2026
Elecsys Anti-SARS-CoV-2 S
K252280 · QVP
Roche Diagnostics
Microbiology · 265d
Cleared Apr 07, 2026
Elecsys Anti-HBc IgM
K260049 · SEI
Roche Diagnostics
Microbiology · 90d
Cleared Apr 07, 2026
Elecsys Anti-HAV IgM
K260048 · LOL
Roche Diagnostics
Microbiology · 90d
Cleared Apr 07, 2026
Elecsys Anti-HBc II
K260046 · SEI
Roche Diagnostics
Microbiology · 90d
Cleared CT Apr 02, 2026
Onclarity™ Self-Collection Kit
K260184 · SEP
Becton, Dickinson and Company
Microbiology · 71d
Cleared Mar 27, 2026
MDx-Chex for BCP
K260041 · PMN
Streck, LLC
Microbiology · 80d
Cleared Mar 26, 2026
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
K260281 · LON
BIOMERIEUX
Microbiology · 56d