BIOCENTREX CARDIAC PANEL

Device Classification Name

biosensor, immunoassay, cpk or isoenzymes

510(k) Number K033155
Device Name BIOCENTREX CARDIAC PANEL
Applicant
BIOCENTREX
6100 bristol parkway
culver city, 
CA 
90230

Applicant Contact thomas h grove
Correspondent
BIOCENTREX
6100 bristol parkway
culver city, 
CA 
90230

Correspodent Contact thomas h grove
Regulation Number 862.1215
Classification Product Code
MYT  
Subsequent Product Codes
DDR   JHX   MMI  
Date Received 09/30/2003
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