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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multi-target respiratory specimen nucleic acid test including sars-cov-2 and other microbial agents
510(k) Number K231758
Device Name NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
Applicant
Luminex Molecular Diagnostics, Inc.
439 University Avenue
Toronto,  CA M5G 1Y8
Applicant Contact Kate Goscha
Correspondent
Luminex Molecular Diagnostics, Inc.
439 University Avenue
Toronto,  CA M5G 1Y8
Correspondent Contact Kate Goscha
Regulation Number866.3981
Classification Product Code
QOF  
Date Received06/16/2023
Decision Date 03/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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