FDA 510(k) Application Details - K971491

Device Classification Name	Analyzer, Chemistry, Micro, For Clinical Use   More FDA Info for this Device
510(K) Number	K971491
Device Name	Analyzer, Chemistry, Micro, For Clinical Use
Applicant	SYNERMED, INC. 1688 50TH AVENUE, MONTREAL (LACHINE), QUEBEC, CANADA H8T 2V5 CA Other 510(k) Applications for this Company
Contact	MARCIA J ARENTZ Other 510(k) Applications for this Contact
Regulation Number	862.2170   More FDA Info for this Regulation Number
Classification Product Code	JJF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/1997
Decision Date	06/26/1997
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