xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)— 510(k) K191160

Substantially Equivalent

Luminex Molecular Diagnostics, Inc.

FDA 510(k) clearance K191160 for xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP), Substantially Equivalent on 2019-11-04. Applicant: Luminex Molecular Diagnostics, Inc..

Clearance details

Applicant: Luminex Molecular Diagnostics, Inc.
Product code: Code PCH
Advisory panel: Microbiology
Date received: 2019-05-01
Decision date: 2019-11-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, CA

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