xTAG Gastrointestinal Pathogen Panel (GPP)— 510(k) K191161

Name: FDA 510(k) clearance K191161
Creator: U.S. Food and Drug Administration
Published: 2019-11-12

Substantially Equivalent

Luminex Molecular Diagnostics, Inc.

FDA 510(k) clearance K191161 for xTAG Gastrointestinal Pathogen Panel (GPP), Substantially Equivalent on 2019-11-12. Applicant: Luminex Molecular Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Luminex Molecular Diagnostics, Inc.
Product code: Code PCH
Device class: Class 2
Regulation: 21 CFR 866.3990
Advisory panel: Microbiology
Date received: 2019-05-01
Decision date: 2019-11-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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