FDA 510(k) Application Details - K961726

Device Classification Name	Calibrators, Drug Specific   More FDA Info for this Device
510(K) Number	K961726
Device Name	Calibrators, Drug Specific
Applicant	ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 BRANCHBURG, NJ 08876-1760 US Other 510(k) Applications for this Company
Contact	MARIA FEIJOO Other 510(k) Applications for this Contact
Regulation Number	862.3200   More FDA Info for this Regulation Number
Classification Product Code	DLJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/1996
Decision Date	07/11/1996
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