FDA 510(k) Application Details - K991070

Device Classification Name	Counter, Cell, Automated (Particle Counter)   More FDA Info for this Device
510(K) Number	K991070
Device Name	Counter, Cell, Automated (Particle Counter)
Applicant	COULTER CORP. 1950 WEST 8TH AVE. HIALEAH, FL 33010 US Other 510(k) Applications for this Company
Contact	THOMAS J ENGLISH Other 510(k) Applications for this Contact
Regulation Number	864.5200   More FDA Info for this Regulation Number
Classification Product Code	GKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/1999
Decision Date	05/11/1999
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