FDA 510(k) Application Details - K220031

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K220031
Device Name	Counter, Differential Cell
Applicant	Abbott Laboratories 4551 Great America Pkwy Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Neha Vatsyayan 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	01/05/2022
Decision Date	08/04/2023
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