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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
Original Applicant
TM BIOSCIENCE CORPORATION
439 university ave.
toronto, ontario,  CA m5g 1y8
Original Contact nancy krunic
Regulation Number866.5900
Classification Product Code
NUA  
Date Received03/15/2006
Decision Date 06/07/2006
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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