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510(k) K143342

Elecsys T-Uptake Calset by Roche Diagnostics — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2014
Date Received
November 21, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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