FDA 510(k) Application Details - K992849

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K992849
Device Name	Counter, Differential Cell
Applicant	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE SPARKS, MD 21152-0999 US Other 510(k) Applications for this Company
Contact	MONICA E GIGUERE 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	08/24/1999
Decision Date	09/23/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review