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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
510(k) Number K043202
Device Name OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
Applicant
Olympus America, Inc.
3131 W. Royal Ln.
Irving,  TX  75063 -3104
Applicant Contact BEV HARDING
Correspondent
Olympus America, Inc.
3131 W. Royal Ln.
Irving,  TX  75063 -3104
Correspondent Contact BEV HARDING
Regulation Number862.1215
Classification Product Code
CGS  
Date Received11/18/2004
Decision Date 12/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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