FDA 510(k) Application Details - K963292

Device Classification Name	Cresolphthalein Complexone, Calcium   More FDA Info for this Device
510(K) Number	K963292
Device Name	Cresolphthalein Complexone, Calcium
Applicant	ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 SOMERVILLE, NJ 08876-3771 US Other 510(k) Applications for this Company
Contact	ANDREA CASPER Other 510(k) Applications for this Contact
Regulation Number	862.1145   More FDA Info for this Regulation Number
Classification Product Code	CIC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/1996
Decision Date	10/31/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review