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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 K152386
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 TINA IP
Correspondent
Luminex Molecular Diagnostics, Inc.
439 University Ave.
Toronto,  CA M5G 1Y8
Correspondent Contact TINA IP
Regulation Number866.3980
Classification Product Code
OCC  
Date Received08/24/2015
Decision Date 12/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01787227
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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