FDA 510(k) Application Details - K011300

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K011300
Device Name	Enzyme Immunoassay, Cannabinoids
Applicant	SYVA CO., DADE BEHRING, INC. 3403 YERBA BUENA RD. SAN JOSE, CA 95135 US Other 510(k) Applications for this Company
Contact	VIRGINIA SINGER Other 510(k) Applications for this Contact
Regulation Number	862.3870   More FDA Info for this Regulation Number
Classification Product Code	LDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2001
Decision Date	05/17/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review