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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 K090541
Device Name ELECSYS PRECICONTROL UNIVERSAL
Applicant
Roche Diagnostics
9115 Hague Rd.
P.O. Box 50410
Indianapolis,  IN  46250
Applicant Contact GAIL SAUERS
Correspondent
Roche Diagnostics
9115 Hague Rd.
P.O. Box 50410
Indianapolis,  IN  46250
Correspondent Contact GAIL SAUERS
Regulation Number862.1660
Classification Product Code
JJY  
Date Received03/02/2009
Decision Date 07/02/2009
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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