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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K103171
Device Name ELECSYS ANTI-TPO CALSET
Applicant
Roche Diagnostics
9115 HAGUE ROAD
P.O. BOX 50416
INDIANAPOLIS,  IN  46250 -0416
Applicant Contact Sarah Baumann
Correspondent
Roche Diagnostics
9115 HAGUE ROAD
P.O. BOX 50416
INDIANAPOLIS,  IN  46250 -0416
Correspondent Contact Sarah Baumann
Regulation Number862.1150
Classification Product Code
JIX  
Date Received10/27/2010
Decision Date 02/11/2011
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
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