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510(k) K112416

CPK REAGENT by Vital Diagnostics (Manufacturing) Ptyltd — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2011
Date Received
August 22, 2011
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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