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510(k) K081533

SENTINEL PLASMAPROTEINS CAL 3X by SENTINEL CH. SpA — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2008
Date Received
June 2, 2008
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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