FDA 510(k) Application Details - K963529

Device Classification Name	Enzyme Immunoassay, Barbiturate   More FDA Info for this Device
510(K) Number	K963529
Device Name	Enzyme Immunoassay, Barbiturate
Applicant	EDITEK, INC. 1238 ANTHONY RD. BOX 908 BURLINGTON, NC 27215 US Other 510(k) Applications for this Company
Contact	CAROLE GOLDEN Other 510(k) Applications for this Contact
Regulation Number	862.3150   More FDA Info for this Regulation Number
Classification Product Code	DIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/04/1996
Decision Date	10/30/1996
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