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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 K820812
Device Name CREATINE KINASE-MB KIT
Applicant
CALBIOCHEM-BEHRING CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CALBIOCHEM-BEHRING CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1215
Classification Product Code
JHY  
Date Received03/23/1982
Decision Date 04/12/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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