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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, cystic fibrosis transmembrane conductance regulator, gene mutation detection
510(K) Number K083845
Device Name XTAG CF60 KIT V2
Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 university ave.
toronto, ontario, 
Contact gloria lee
Regulation Number866.5900
Classification Product Code
NUA  
Date Received12/24/2008
Decision Date 12/11/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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