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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 K980012
Device Name CREATINE KINASE REAGENT
Applicant
Ac Biochemicals, Inc.
17955 Sky Park Circle, Suite J
Irvine,  CA  92614
Applicant Contact CHARLES C ALLAIN
Correspondent
Ac Biochemicals, Inc.
17955 Sky Park Circle, Suite J
Irvine,  CA  92614
Correspondent Contact CHARLES C ALLAIN
Regulation Number862.1215
Classification Product Code
JHX  
Date Received01/02/1998
Decision Date 02/25/1998
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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