FDA 510(k) Application Details - K974909

Device Classification Name	Alkaline Picrate, Colorimetry, Creatinine   More FDA Info for this Device
510(K) Number	K974909
Device Name	Alkaline Picrate, Colorimetry, Creatinine
Applicant	SYNERMED INTL., INC. 1688 50TH AVE. LACHINE, QUEBEC H8T 2V5 CA Other 510(k) Applications for this Company
Contact	MARCIA J ARENTZ Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	CGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/1997
Decision Date	02/24/1998
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