FDA 510(k) Application Details - K991605

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K991605
Device Name	Counter, Differential Cell
Applicant	ABBOTT LABORATORIES 5440 PATRICK HENRY DR. SANTA CLARA, CA 95054 US Other 510(k) Applications for this Company
Contact	MICHELLE B ROEDING 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	05/10/1999
Decision Date	07/09/1999
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