FDA 510(k) Application Details - K974053

Device Classification Name	Catalytic Methods, Amylase   More FDA Info for this Device
510(K) Number	K974053
Device Name	Catalytic Methods, Amylase
Applicant	DIAGNOSTIC CHEMICALS LTD. 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK CHARLOTTETOWN, P.E.I. C1E1B0 CA Other 510(k) Applications for this Company
Contact	KAREN CALLBECK Other 510(k) Applications for this Contact
Regulation Number	862.1070   More FDA Info for this Regulation Number
Classification Product Code	JFJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/1997
Decision Date	12/08/1997
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