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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 K112199
Model 1019C0111, 3N30-01, S019-0116, 3N30-10
Device Name XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
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
NSU   OEM   OEP  
Date Received08/10/2011
Decision Date 09/01/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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