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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name U.V. Method, Cpk Isoenzymes
510(k) Number K942958
Device Name CREATINE KINASE MB DETERMINATION (UV)
Applicant
Biochemical Trade, Inc.
7522 NW 55th St.
Miami,  FL  33166
Applicant Contact ALEJO V ROY, PH.D.
Correspondent
Biochemical Trade, Inc.
7522 NW 55th St.
Miami,  FL  33166
Correspondent Contact ALEJO V ROY, PH.D.
Regulation Number862.1215
Classification Product Code
JHW  
Date Received06/23/1994
Decision Date 11/21/1994
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
Recalls CDRH Recalls
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