FDA 510(k) Application Details - K981568

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K981568
Device Name	Counter, Differential Cell
Applicant	CDC TECHNOLOGIES, INC. 1250 24TH STREET, N.W. 7TH FL WASHINGTON, DC 20037 US Other 510(k) Applications for this Company
Contact	GEORGE J WALLACE Other 510(k) Applications for this Contact
Regulation Number	864.5220   More FDA Info for this Regulation Number
Classification Product Code	GKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/1998
Decision Date	08/21/1998
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