FDA 510(k) Application Details - K971841

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K971841
Device Name	Enzyme Immunoassay, Cannabinoids
Applicant	BIONIKE LABORATORIES, INC. 1015 GRANDVIEW DR. SOUTH SAN FRANCISCO, CA 94080-4910 US Other 510(k) Applications for this Company
Contact	JANIS FREESTONE 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	05/19/1997
Decision Date	06/25/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review