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
169–192 of 7,061
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jan 16, 2025
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
K243885 · PCH
Biofire Diagnostics, LLC
Microbiology · 29d
Cleared Jan 16, 2025
WELLlife™ COVID-19 / Influenza A&B Home Test
K243256 · SCA
Wondfo USA Co., Ltd.
Microbiology · 93d
Cleared Jan 16, 2025
cobas® liat CT/NG/MG nucleic acid test
K240197 · QEP
Roche Molecular Systems, Inc.
Microbiology · 357d
Cleared Jan 15, 2025
Xpert® Xpress CoV-2 plus (XPRS-COV2-10)
K242109 · QQX
Cepheid
Microbiology · 180d
Cleared Jan 13, 2025
QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen...
K243262 · SCA
Osang, LLC
Microbiology · 90d
Cleared Jan 10, 2025
BioCode Gastrointestinal Pathogen Panel (GPP)
K242877 · PCH
Applied BioCode, Inc.
Microbiology · 109d
Cleared Jan 10, 2025
Xpert Xpress CoV-2/Flu/RSV plus
K242071 · QOF
Cepheid
Microbiology · 178d
Cleared Jan 10, 2025
TriVerity
K241676 · PRE
Inflammatix, Inc.
Microbiology · 213d
Cleared Jan 08, 2025
QIAstat-Dx GI Panel 2 Mini B&V
K243813 · PCH
QIAGEN GmbH
Microbiology · 28d
Cleared Jan 08, 2025
Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel
K241806 · QOF
Life Technologies Corporation
Microbiology · 201d
Cleared Dec 20, 2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)...
K243759 · PEN
Biofire Diagnostics, LLC
Microbiology · 14d
Cleared Dec 20, 2024
DASH® SARS-CoV-2 & Flu A/B Test
K241652 · QOF
Nuclein, LLC
Microbiology · 196d
Cleared Dec 19, 2024
BD Vaginal Panel
K243725 · PQA
Becton, Dickinson and Company
Microbiology · 16d
Cleared Dec 19, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K243169 · JWY
Thermo Fisher Scientific
Microbiology · 80d
Cleared Dec 18, 2024
Xpert MRSA/SA SSTI
K243625 · NQX
Cepheid
Microbiology · 23d
Cleared Dec 06, 2024
Alinity m SARS-CoV-2 AMP Kit (09N78-096)
K241580 · QQX
Abbott Molecular
Microbiology · 186d
Cleared Dec 05, 2024
BIOFIRE FILMARRAY Tropical Fever Panel
K243463 · QMV
Biofire Diagnostics, LLC (Biomerieux)
Microbiology · 27d
Cleared Dec 05, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242653 · JWY
Thermo Fisher Scientific
Microbiology · 92d
Cleared Nov 26, 2024
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K242657 · JWY
Thermo Fisher Scientific
Microbiology · 83d
Cleared Nov 25, 2024
Aptima BV Assay
K243345 · PQA
Hologic, Inc.
Microbiology · 28d
Cleared Nov 21, 2024
Xpert vanA
K243405 · NIJ
Cepheid
Microbiology · 20d
Cleared Nov 15, 2024
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
K242465 · QOF
Hologic, Inc.
Microbiology · 87d
Cleared Nov 07, 2024
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
K242367 · PCH
Biofire Diagnostics, LLC
Microbiology · 90d
Cleared Nov 06, 2024
BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel)
K243222 · QDS
Biofire Diagnostics, LLC (Biomerieux)
Microbiology · 30d