FDA 510(k) Application Details - K052794

Device Classification Name	Analyzer, Chemistry, Micro, For Clinical Use   More FDA Info for this Device
510(K) Number	K052794
Device Name	Analyzer, Chemistry, Micro, For Clinical Use
Applicant	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US Other 510(k) Applications for this Company
Contact	CAROL A DEPOUW 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	10/03/2005
Decision Date	03/31/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review