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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
510(k) Number K191160
Device Name xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
Applicant
Luminex Molecular Diagnostics, Inc.
439 University Avenue
Toronto,  CA M5g 1y8
Applicant Contact Tina Ip
Correspondent
Luminex Molecular Diagnostics, Inc.
439 University Avenue
Toronto,  CA M5g 1y8
Correspondent Contact Tina Ip
Regulation Number866.3990
Classification Product Code
PCH  
Date Received05/01/2019
Decision Date 11/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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