FDA 510(k) Application Details - K232600

Device Classification Name	More FDA Info for this Device
510(K) Number	K232600
Device Name	DxFLEX Flow Cytometer; ClearLLab 10C Panels
Applicant	Beckman Coulter, Inc 11800 SW 147 Ave Miami, FL 33196 US Other 510(k) Applications for this Company
Contact	Stephanie Harlacz Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2023
Decision Date	11/22/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review