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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, calcitonin
510(k) Number K132828
Device Name ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA 3
Applicant
Roche Diagnostics
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250 -0416
Applicant Contact KELLI TURNER
Correspondent
Roche Diagnostics
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250 -0416
Correspondent Contact KELLI TURNER
Regulation Number862.1140
Classification Product Code
JKR  
Subsequent Product Codes
JIT   JJY  
Date Received09/09/2013
Decision Date 12/04/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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