FDA 510(k) Application Details - K961439

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K961439
Device Name	Counter, Differential Cell
Applicant	ABBOTT DIAGNOSTICS 5440 PATRICK HENRY DR. SANTA CLARA, CA 95054 US Other 510(k) Applications for this Company
Contact	JANICE E BROWN 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	04/15/1996
Decision Date	10/18/1996
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