FDA 510(k) Application Details - K961393

Device Classification Name	U.V. Spectrometry, Tricyclic Antidepressant Drugs   More FDA Info for this Device
510(K) Number	K961393
Device Name	U.V. Spectrometry, Tricyclic Antidepressant Drugs
Applicant	DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. SUNNYVALE, CA 94086 US Other 510(k) Applications for this Company
Contact	YUH-GENG TSAY, PH.D. Other 510(k) Applications for this Contact
Regulation Number	862.3910   More FDA Info for this Regulation Number
Classification Product Code	LFH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/1996
Decision Date	06/12/1996
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