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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 K112113
Device Name ELECSYS MYOGLOBIN CALCHECK 5
Original Applicant
Roche Diagnostics
9115 hague road
indianapolis,  IN  46250 -0416
Original Contact kelly colleen o'maine adams
Regulation Number862.1660
Classification Product Code
JJX  
Date Received07/25/2011
Decision Date 09/14/2011
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
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