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
49–72 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
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
Cleared Nov 20, 2025
cobas liat Bordetella panel nucleic acid test
K243753 · OZZ
Roche Molecular Systems, Inc.
Microbiology · 350d
Cleared Nov 19, 2025
IntelliSep Test
K250912 · QUT
Cytovale, Inc.
Microbiology · 237d
Cleared Nov 17, 2025
Access Rubella IgG
K250588 · LFX
Beckman Coulter, Inc.
Microbiology · 263d
Cleared Nov 14, 2025
Lyme-ID IgG Test
K252627 · LSR
Inanovate, Inc.
Microbiology · 86d
Cleared Nov 14, 2025
Status™ COVID-19/Flu A&B
K251538 · SCA
Princeton BioMeditech Corp.
Microbiology · 179d
Cleared Nov 03, 2025
cobas HCV
K252484 · MZP
Roche Molecular Systems, Inc.
Microbiology · 88d
Cleared Nov 03, 2025
cobas CMV
K252481 · PAB
Roche Molecular Systems, Inc.
Microbiology · 88d
Cleared Oct 31, 2025
BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus...
K250358 · PCI
Becton, Dickinson and Company
Microbiology · 266d
Cleared Oct 30, 2025
Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450)
K252387 · QOF
Diasorin Molecular, LLC
Microbiology · 91d
Cleared Oct 27, 2025
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
K251875 · SAN
Affinity Biosensors, LLC
Microbiology · 131d