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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K133284
Device Name ELECSYS CK-MB CALCHECK 5
Applicant
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact KELLI TURNER
Correspondent
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact KELLI TURNER
Regulation Number862.1660
Classification Product Code
JJX  
Date Received10/25/2013
Decision Date 11/22/2013
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
Predetermined Change
Control Plan Authorized		 No
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