FDA 510(k) Application Details - K033155

Device Classification Name	Biosensor, Immunoassay, Cpk Or Isoenzymes   More FDA Info for this Device
510(K) Number	K033155
Device Name	Biosensor, Immunoassay, Cpk Or Isoenzymes
Applicant	BIOCENTREX 6100 BRISTOL PARKWAY CULVER CITY, CA 90230 US Other 510(k) Applications for this Company
Contact	THOMAS H GROVE Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	MYT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2003
Decision Date	01/12/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review