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510(k) K103171

ELECSYS ANTI-TPO CALSET by Roche Diagnostics — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2011
Date Received
October 27, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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