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
73–96 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 24, 2026
FebriDx Bacterial/Non-bacterial Assay
K260787 · QXA
Lumos Diagnostics, Inc.
Microbiology · 14d
Cleared Mar 23, 2026
MDx-Chex for BCN
K254166 · PMN
Streck
Microbiology · 90d
Cleared Mar 17, 2026
MDx-Chex for BCY
K254167 · PMN
Streck, LLC
Microbiology · 84d
Cleared Mar 13, 2026
Access anti-HBc IgM
K254059 · SEI
Beckman Coulter, Inc.
Microbiology · 86d
Cleared Mar 13, 2026
GenBody COVID-19 Ag Home Test
K251916 · QYT
Genbody.Inc.
Microbiology · 263d
Cleared Mar 09, 2026
QIAstat-Dx Gastrointestinal Panel 2
K254032 · PCH
QIAGEN GmbH
Microbiology · 83d
Cleared Feb 20, 2026
Xpert Hemorrhagic Fever
K253653
Cepheid
Microbiology · 92d
Cleared Feb 19, 2026
Access anti-HBc Total
K253687 · SEI
Beckman Coulter, Inc.
Microbiology · 90d
Cleared Feb 13, 2026
VELO Respiratory Test
K251742 · QOF
Lex Diagnostics Limited
Microbiology · 252d
Cleared Jan 30, 2026
Clungene RSV Antigen Rapid Test
K253318 · GQG
Hangzhou Clongene Biotech Co., Ltd.
Microbiology · 122d
Cleared Jan 27, 2026
Access anti-HAV IgM
K251995 · LOL
Beckman Coulter, Inc.
Microbiology · 214d
Cleared Jan 22, 2026
PhenoMATRIX
K251511 · PPU
Copan Wasp Srl
Microbiology · 251d
Cleared Jan 16, 2026
Xpert GI Panel
K251721 · PCH
Cepheid
Microbiology · 226d
Cleared Jan 15, 2026
Nano-Check Influenza A+B Test
K252283 · PSZ
Nano-Ditech Corporation
Microbiology · 177d
Cleared Dec 30, 2025
Multichem ID-G (09339892190)
K242492 · QCH
Techno-Path Manufacturing , Ltd.
Microbiology · 496d
Cleared Dec 23, 2025
LIAISON NES FLU A/B, RSV & COVID-19
K251978 · QOF
Diasorin Molecular, LLC
Microbiology · 179d
Not Cleared Dec 23, 2025
LIAISON® XL MUREX Anti-HDV (318260)
DEN250032 · SGW
DiaSorin, Inc.
Microbiology · 146d
Cleared Dec 17, 2025
Elecsys Anti-SARS-CoV-2
K253839 · QVP
Roche Diagnostics
Microbiology · 16d
Cleared Dec 12, 2025
iHealth Flu A&B/COVID-19 Rapid Test
K251092 · SCA
Ihealth Labs, Inc.
Microbiology · 246d
Cleared Dec 12, 2025
iHealth Flu A&B/COVID-19/RSV Rapid Test
K251085 · SCA
Ihealth Labs, Inc.
Microbiology · 247d
Cleared Dec 05, 2025
Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
K251337 · JTN
Thermo Fisher Scientific (Oxoid Ltd.)
Microbiology · 219d
Cleared Nov 26, 2025
Flowflex® Plus Strep A Rapid Test Cassette
K251697 · GTY
ACON Laboratories, Inc.
Microbiology · 177d
Cleared Nov 26, 2025
Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport...
K242976 · JSM
Medical Wire & Equipment Company...
Microbiology · 426d
Cleared Nov 20, 2025
HardyDisk AST Cefiderocol 30µg (FDC30)
K253105 · JTN
Hardy Diagnostics
Microbiology · 57d