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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 K060543
Device Name ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800
Applicant
CLINICAL MICRO SENSORS, INC.
757 SOUTH RAYMOND AVE.
pasadena,  CA  91105
Applicant Contact william coty
Correspondent
CLINICAL MICRO SENSORS, INC.
757 SOUTH RAYMOND AVE.
pasadena,  CA  91105
Correspondent Contact william coty
Regulation Number866.5900
Classification Product Code
NUA  
Date Received03/01/2006
Decision Date 03/28/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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