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510(k) K142181

RANDOX ALDOLASE CALIBRATION SERUM by Randox Laboratories Limited — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2014
Date Received
August 8, 2014
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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