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510(k) K070971

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2007
Date Received
April 6, 2007
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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