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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 K083846
Device Name XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 UNIVERSITY AVE.
toronto, ontario,  CA m5g 1y8
Applicant Contact gloria lee
Correspondent
LUMINEX MOLECULAR DIAGNOSTICS, INC.
439 UNIVERSITY AVE.
toronto, ontario,  CA m5g 1y8
Correspondent Contact gloria lee
Regulation Number866.5900
Classification Product Code
NUA  
Date Received12/24/2008
Decision Date 09/01/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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