FDA 510(k) Application Details - K002792

Device Classification Name	Colorimetry, Cholinesterase   More FDA Info for this Device
510(K) Number	K002792
Device Name	Colorimetry, Cholinesterase
Applicant	CARESIDE, INC. 6100 BRISTOL PKWY. CULVER CITY, CA 90230 US Other 510(k) Applications for this Company
Contact	KENNETH B ASARCH Other 510(k) Applications for this Contact
Regulation Number	862.3240   More FDA Info for this Regulation Number
Classification Product Code	DIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2000
Decision Date	11/08/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review