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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
Applicant
CELERA DIAGNOSTICS
1401 HARBOR BAY PKWY.
alameda,  CA  94502
Applicant Contact victoria mackinnon
Correspondent
CELERA DIAGNOSTICS
1401 HARBOR BAY PKWY.
alameda,  CA  94502
Correspondent Contact victoria mackinnon
Regulation Number866.5900
Classification Product Code
NUA  
Date Received07/18/2006
Decision Date 09/07/2007
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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