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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Differential Rate Kinetic Method, Cpk Or Isoenzymes
510(k) Number K102706
Device Name CKMB UDR ASSAY
Applicant
SENTINEL CH. SpA
Via Robert Koch 2
Milan,  IT 20152
Applicant Contact FABIO ROTA
Correspondent
SENTINEL CH. SpA
Via Robert Koch 2
Milan,  IT 20152
Correspondent Contact FABIO ROTA
Regulation Number862.1215
Classification Product Code
JHS  
Date Received09/20/2010
Decision Date 08/19/2011
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
Predetermined Change
Control Plan Authorized		 No
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