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510(k) K994189

OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 by Olympus Diagnostica GmbH — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2000
Date Received
December 13, 1999
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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  • K982035 — OLYMPUS CALCIUM ARSENAZO III REAGENT (June 24, 1998)

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