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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 K242613
Device Name NxTAG® Respiratory Pathogen Panel
Applicant
Luminex Molecular Diagnostics, Inc.
439 University Ave.
Toronto,  CA M5G 1Y8
Applicant Contact Tara Vivian
Correspondent
Luminex Molecular Diagnostics, Inc.
439 University Ave.
Toronto,  CA M5G 1Y8
Correspondent Contact Tara Vivian
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
NXD   OEM   OEP   OOI   OOU  
OTG   OZX   OZY  
Date Received09/03/2024
Decision Date 10/02/2024
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
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