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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
Original Applicant
OSMETECH MOLECULAR DIAGNOSTICS
757 south raymond ave.
pasadena,  CA  91105
Original 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 - 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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