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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 K111506
Device Name ELECSYS PRECICONTROL VARIA 3
Applicant
Roche Diagnostics
9115 HAGUE ROAD
P.O. BOX 50410
INDIANAPOLIS,  IN  46250 -0416
Applicant Contact Sarah Baumann
Correspondent
Roche Diagnostics
9115 HAGUE ROAD
P.O. BOX 50410
INDIANAPOLIS,  IN  46250 -0416
Correspondent Contact Sarah Baumann
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/01/2011
Decision Date 07/08/2011
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
Recalls CDRH Recalls
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