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510(k) K072548

CREATINE KINASE LIQUID REAGENT, MODEL C519-440 by Teco Diagnostics — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2008
Date Received
September 10, 2007
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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