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510(k) K123372

ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR by Abbott Laboratories — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2013
Date Received
November 1, 2012
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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