FDA 510(k) Application Details - K982166

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K982166
Device Name	Counter, Differential Cell
Applicant	COULTER CORP. 11800 S.W. 147TH AVE. MAIL CODE 31-B06 MIAMI, FL 33196-2500 US Other 510(k) Applications for this Company
Contact	MARION S GAIDE 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	06/19/1998
Decision Date	11/05/1998
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