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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 K043011
Device Name TAG-IT CYSTIC FIBROSIS KIT
Original Applicant
TM BIOSCIENCE CORPORATION
439 university ave., suite 900
toronto, ontario,  CA m5g 1y8
Original Contact nancy krunic
Regulation Number866.5900
Classification Product Code
NUA  
Date Received11/01/2004
Decision Date 05/09/2005
Decision de novo petitions granted (AN)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
FOI Item Approval Letter
FDA Review Decision Summary
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
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