FDA 510(k) Application Details - K100684

Device Classification Name	Apparatus, Automated Blood Cell Diluting   More FDA Info for this Device
510(K) Number	K100684
Device Name	Apparatus, Automated Blood Cell Diluting
Applicant	VERIDEX, LLC 1001 US HIGHWAY 202 NORTH RARITAN, NJ 08869-0606 US Other 510(k) Applications for this Company
Contact	SARAH MCMANUS Other 510(k) Applications for this Contact
Regulation Number	864.5240   More FDA Info for this Regulation Number
Classification Product Code	GKH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/2010
Decision Date	08/26/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review