FDA 510(k) Application Details - K955770

Device Classification Name	Kinetic Method, Gamma-Glutamyl Transpeptidase   More FDA Info for this Device
510(K) Number	K955770
Device Name	Kinetic Method, Gamma-Glutamyl Transpeptidase
Applicant	ABAXIS, INC. 1320 CHESAPEAKE TERRACE SUNNYVALE, CA 94089 US Other 510(k) Applications for this Company
Contact	DANIEL WONG 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	12/21/1995
Decision Date	09/09/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review