FDA 510(k) Application Details - K181475

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K181475
Device Name	Counter, Differential Cell
Applicant	Beckman Coulter 11800 SW 147th Ave Miami, FL 33196-2500 US Other 510(k) Applications for this Company
Contact	Samy Puccio 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	06/04/2018
Decision Date	03/01/2019
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review