FDA 510(k) Application Details - K983268

Device Classification Name	U.V. Spectrometry, Tricyclic Antidepressant Drugs   More FDA Info for this Device
510(K) Number	K983268
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 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	09/17/1998
Decision Date	11/18/1998
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