K183023

Substantially Equivalent

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

Applicant: Luminex Molecular Diagnostics, Inc.
Product code: PCH
Advisory panel: Microbiology
Date received: 2018-11-01
Decision date: 2018-11-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Toronto, CA

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