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510(k) K043202

OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 by Olympus America, Inc. — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2004
Date Received
November 18, 2004
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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