FDA 510(k) Application Details - K963606

Device Classification Name	Enzyme Immunoassay, Cannabinoids   More FDA Info for this Device
510(K) Number	K963606
Device Name	Enzyme Immunoassay, Cannabinoids
Applicant	SUN BIOMEDICAL LABORATORIES, INC. 2040 FAIRFAX AVE. CHERRY HILL, NJ 08003 US Other 510(k) Applications for this Company
Contact	MING SUN 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	09/09/1996
Decision Date	10/30/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review