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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 K062028
Device Name CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01
Original Applicant
CELERA DIAGNOSTICS
1401 harbor bay pkwy.
alameda,  CA  94502
Original Contact victoria mackinnon
Regulation Number866.5900
Classification Product Code
NUA  
Date Received07/18/2006
Decision Date 09/07/2007
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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