FDA 510(k) Application Details - K072062

Device Classification Name	Radioimmunoassay, Tricyclic Antidepressant Drugs   More FDA Info for this Device
510(K) Number	K072062
Device Name	Radioimmunoassay, Tricyclic Antidepressant Drugs
Applicant	UCP BIOSCIENCES, INC. 1445 KOLL CIRCLE, STE. 111 SAN JOSE, CA 95112 US Other 510(k) Applications for this Company
Contact	NANCY CHEN Other 510(k) Applications for this Contact
Regulation Number	862.3910   More FDA Info for this Regulation Number
Classification Product Code	LFG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2007
Decision Date	09/20/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review