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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 K090901
Device Name ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8
Applicant
Osmetech Molecular Diagnostics
757 S. Raymond Ave.
Pasadena,  CA  91105
Applicant Contact ROBERT S DICHECK
Correspondent
Osmetech Molecular Diagnostics
757 S. Raymond Ave.
Pasadena,  CA  91105
Correspondent Contact ROBERT S DICHECK
Regulation Number866.5900
Classification Product Code
NUA  
Subsequent Product Code
NSU  
Date Received04/01/2009
Decision Date 07/06/2009
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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