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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometric Method, Cpk Or Isoenzymes
510(k) Number K881267
Device Name BIOTROL CK MONOEACTIF
Applicant
Biotrol, USA, Inc.
5 Great Valley Pkwy., Suite 248
Great Valley Corp. Center
Malvern,  PA  19355
Applicant Contact ALLAN C MURPHY
Correspondent
Biotrol, USA, Inc.
5 Great Valley Pkwy., Suite 248
Great Valley Corp. Center
Malvern,  PA  19355
Correspondent Contact ALLAN C MURPHY
Regulation Number862.1215
Classification Product Code
JHX  
Date Received03/24/1988
Decision Date 05/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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