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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 K051435
Device Name ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800
Applicant
CLINICAL MICRO SENSORS
757 SOUTH RAYMOND AVENUE
PASADENA,  CA  91105
Applicant Contact WILLIAM A COTY
Correspondent
CLINICAL MICRO SENSORS
757 SOUTH RAYMOND AVENUE
PASADENA,  CA  91105
Correspondent Contact WILLIAM A COTY
Regulation Number866.5900
Classification Product Code
NUA  
Date Received06/01/2005
Decision Date 01/19/2006
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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