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
193–216 of 7,095
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 12, 2025
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG...
K243575 · MYF
Biokit, S.A.
Microbiology · 85d
Cleared Feb 11, 2025
BinaxNOW™ COVID-19 Antigen Self Test
K243518 · QYT
Abbott Diagnostics Scarborough, Inc.
Microbiology · 90d
Cleared Feb 11, 2025
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
K240867 · QQX
Roche Molecular Systems, Inc.
Microbiology · 319d
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K243201 · JWY
Thermo Fisher Scientific
Microbiology · 132d
Cleared Feb 10, 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K242905 · JWY
Thermo Fisher Scientific
Microbiology · 139d
Cleared Jan 30, 2025
simpli-COLLECT STI Test
K243410 · QYA
Abbott Molecular
Microbiology · 90d
Cleared Jan 30, 2025
MTS Ceftobiprole 0.002-32 µg/mL
K243202 · JWY
Liofilchem S. R. L.
Microbiology · 121d
Cleared Jan 29, 2025
CareSuperb™ COVID-19 Antigen Home Test
K241915 · QYT
Access Bio, Inc.
Microbiology · 212d
Cleared Jan 17, 2025
Aptima CMV Quant Assay
K243935 · PAB
Hologic, Inc.
Microbiology · 28d
Cleared Jan 17, 2025
cobas® liat CT/NG nucleic acid test
K240217 · QEP
Roche Molecular Systems, Inc.
Microbiology · 357d
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 CT 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