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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Virus Panel Nucleic Acid Assay System
510(k) Number K193167
Device Name NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
Applicant
Luminex Molecular Diagnostics, Inc.
439 University Ave.
Toronto,  CA M5G 1Y8
Applicant Contact Jennifer Grimes
Correspondent
Luminex Molecular Diagnostics, Inc.
439 University Ave.
Toronto,  CA M5G 1Y8
Correspondent Contact Jennifer Grimes
Regulation Number866.3980
Classification Product Code
OCC  
Date Received11/15/2019
Decision Date 12/11/2019
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
Recalls CDRH Recalls
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