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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biosensor, Immunoassay, Cpk Or Isoenzymes
510(k) Number K033155
Device Name BIOCENTREX CARDIAC PANEL
Applicant
Biocentrex
6100 Bristol Pkwy.
Culver City,  CA  90230
Applicant Contact THOMAS H GROVE
Correspondent
Biocentrex
6100 Bristol Pkwy.
Culver City,  CA  90230
Correspondent Contact THOMAS H GROVE
Regulation Number862.1215
Classification Product Code
MYT  
Subsequent Product Codes
DDR   JHX   MMI  
Date Received09/30/2003
Decision Date 01/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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