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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Cpk Or Isoenzymes
510(k) Number K070835
Device Name OLYMPUS CK-MB REAGENT
Applicant
Olympus Life & Material Science Europa GmbH (Irish
Lismeehan
O'Callaghans Mills, Co. Clare,  IE
Applicant Contact STEPHANIE G SCHWARTZ
Correspondent
Olympus Life & Material Science Europa GmbH (Irish
Lismeehan
O'Callaghans Mills, Co. Clare,  IE
Correspondent Contact STEPHANIE G SCHWARTZ
Regulation Number862.1215
Classification Product Code
JHY  
Date Received03/27/2007
Decision Date 06/04/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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