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510(k) K051452

SENTINEL CLIN CHEM CAL by Sentinel Ch. Srl — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2005
Date Received
June 2, 2005
Clearance Type
Abbreviated
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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