FDA 510(k) Application Details - K190294

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K190294
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	Madhu Gill 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	02/11/2019
Decision Date	03/15/2019
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