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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
Device Name XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 UNIVERSITY AVE.
SUITE 900
TORONTO, ONTARIO,  CA M5G 1Y8
Applicant Contact LUBNA SYED
Correspondent
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 UNIVERSITY AVE.
SUITE 900
TORONTO, ONTARIO,  CA M5G 1Y8
Correspondent Contact LUBNA SYED
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
NSU   OEM   OEP  
Date Received08/01/2011
Decision Date 09/01/2011
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
Recalls CDRH Recalls
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