FDA 510(k) Application Details - K240402

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K240402
Device Name	Counter, Differential Cell
Applicant	CytoChip Inc. 18 Technology Dr, Suite 200 Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Wendian Shi 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	02/09/2024
Decision Date	02/03/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review