FDA 510(k) Application Details - K961919

Device Classification Name	Colorimetric Method, Gamma-Glutamyl Transpeptidase   More FDA Info for this Device
510(K) Number	K961919
Device Name	Colorimetric Method, Gamma-Glutamyl Transpeptidase
Applicant	DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST ARLINGTON, TX 76011 US Other 510(k) Applications for this Company
Contact	C.H. MORRIS Other 510(k) Applications for this Contact
Regulation Number	862.1360   More FDA Info for this Regulation Number
Classification Product Code	JPZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/1996
Decision Date	07/01/1996
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