FDA 510(k) Application Details - K973157

Device Classification Name	Kinetic Method, Gamma-Glutamyl Transpeptidase   More FDA Info for this Device
510(K) Number	K973157
Device Name	Kinetic Method, Gamma-Glutamyl Transpeptidase
Applicant	POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. LINCOLN PARK, MI 48146 US Other 510(k) Applications for this Company
Contact	WILLIAM F WALTERS 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	08/22/1997
Decision Date	10/10/1997
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