FDA 510(k) Application Details - K973628

Device Classification Name	Analyzer, Chemistry, Micro, For Clinical Use   More FDA Info for this Device
510(K) Number	K973628
Device Name	Analyzer, Chemistry, Micro, For Clinical Use
Applicant	VITAL SCIENTIFIC N.V. ONE GATEWAY CENTER SUITE 415 NEWTON, MA 02158 US Other 510(k) Applications for this Company
Contact	ISRAEL M STEIN 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	09/24/1997
Decision Date	03/13/1998
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