FDA 510(k) Application Details - K964457

Device Classification Name	Kinetic Method, Gamma-Glutamyl Transpeptidase   More FDA Info for this Device
510(K) Number	K964457
Device Name	Kinetic Method, Gamma-Glutamyl Transpeptidase
Applicant	ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 BRANCHBURG, NJ 08876-1760 US Other 510(k) Applications for this Company
Contact	RITA SMITH Other 510(k) Applications for this Contact
Regulation Number	862.1360   More FDA Info for this Regulation Number
Classification Product Code	JQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/1996
Decision Date	01/13/1997
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