FDA 510(k) Application Details - K201814

Device Classification Name	More FDA Info for this Device
510(K) Number	K201814
Device Name	BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules,
Applicant	Becton, Dickinson and Company 2350 Qume Dr. San Jose, CA 95131 US Other 510(k) Applications for this Company
Contact	Niya Su 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	07/01/2020
Decision Date	09/28/2020
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