FDA 510(k) Application Details - K040898

Device Classification Name	Control Material, Blood Circulating Epithelial Cancer Cell   More FDA Info for this Device
510(K) Number	K040898
Device Name	Control Material, Blood Circulating Epithelial Cancer Cell
Applicant	VERIDEX, LLC 1001 US HWY 202 RARITAN, NJ 08869-0606 US Other 510(k) Applications for this Company
Contact	DEBRA J RASMUSSEN Other 510(k) Applications for this Contact
Regulation Number	864.8625   More FDA Info for this Regulation Number
Classification Product Code	NRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2004
Decision Date	06/28/2004
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