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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K102157
Device Name ELECSYS PRECICONTROL MULTIMARKER
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact Sarah Baumann
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact Sarah Baumann
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/30/2010
Decision Date 08/27/2010
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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