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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 K103776
Model I025C0197, 5N01-01, S025-0245, 5N01-10
Device Name XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST
Original Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 university ave.
suite 900
toronto, ontario,  CA m5g 1y8
Original Contact lubna syed
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OEM   OEP  
Date Received12/27/2010
Decision Date 07/01/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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