FDA 510(k) Application Details - K964212

Device Classification Name	Enzyme Immunoassay, Quinidine   More FDA Info for this Device
510(K) Number	K964212
Device Name	Enzyme Immunoassay, Quinidine
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	862.3320   More FDA Info for this Regulation Number
Classification Product Code	LBZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/22/1996
Decision Date	12/18/1996
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