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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 K112781
Models I019C0111, 3N301-01, S019-0116, 3N30-10
Device Name TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)
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
JJH   NSU   OEM   OEP  
Date Received09/26/2011
Decision Date 02/17/2012
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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