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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 K060627
Device Name TAG-IT CYSTIC FIBROSIS KIT
Applicant
TM BIOSCIENCE CORPORATION
439 UNIVERSITY AVE.
toronto, ontario,  CA m5g 1y8
Applicant Contact nancy krunic
Correspondent
TM BIOSCIENCE CORPORATION
439 UNIVERSITY AVE.
toronto, ontario,  CA m5g 1y8
Correspondent Contact nancy krunic
Regulation Number866.5900
Classification Product Code
NUA  
Date Received03/09/2006
Decision Date 06/07/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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