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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 K081483
Device Name XTAG RESPIRATORY VIRAL PANEL
Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 university ave.
toronto, ontario, 
Contact gloria lee
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OEM   OEP  
Date Received05/28/2008
Decision Date 06/25/2008
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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