FDA 510(k) Application Details - K022331

Device Classification Name	Counter, Cell, Automated (Particle Counter)   More FDA Info for this Device
510(K) Number	K022331
Device Name	Counter, Cell, Automated (Particle Counter)
Applicant	BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. TARRYTOWN, NY 10591-5097 US Other 510(k) Applications for this Company
Contact	KENNETH T EDDS 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	07/18/2002
Decision Date	09/11/2002
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