FDA 510(k) Application Details - K971361

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K971361
Device Name	Enzyme Immunoassay, Opiates
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	862.3650   More FDA Info for this Regulation Number
Classification Product Code	DJG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/1997
Decision Date	06/06/1997
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