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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 K122242
Device Name ELECSYS CA 15-3 II CALCHECK 5
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250 -0416
Applicant Contact EDIE EADS
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250 -0416
Correspondent Contact EDIE EADS
Regulation Number862.1660
Classification Product Code
JJX  
Date Received07/27/2012
Decision Date 12/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
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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