FDA 510(k) Application Details - K964754

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K964754
Device Name	Counter, Differential Cell
Applicant	ORTHO DIAGNOSTIC SYSTEMS, INC. 1001 U.S. HIGHWAY 202 P.O. BOX 350 RARITAN, NJ 08869-0606 US Other 510(k) Applications for this Company
Contact	JOANNE HARRIS 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	11/27/1996
Decision Date	01/22/1997
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