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510(k) K123977

RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR by Randox Laboratories, Ltd. — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2013
Date Received
December 26, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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