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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 K884550
Device Name CREATINE KINASE MB ENZYME IMMUNOASSAY KIT
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact J ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact J ARNSBERGER
Regulation Number862.1215
Classification Product Code
JHY  
Date Received10/31/1988
Decision Date 02/23/1989
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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