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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Atp And Creatine Kinase (Enzymatic), Creatine
510(k) Number K971817
Device Name OLYMPUS CK-MB REAGENT
Applicant
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747 -3157
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747 -3157
Correspondent Contact LAURA STORMS-TYLER
Regulation Number862.1210
Classification Product Code
JLB  
Date Received05/16/1997
Decision Date 06/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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