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510(k) K170938

CalSet IGF-1 by Roche Diagnostics — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2017
Date Received
March 30, 2017
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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