FDA 510(k) Application Details - K170974

Device Classification Name	More FDA Info for this Device
510(K) Number	K170974
Device Name	BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK
Applicant	Becton, Dickinson and Company 2350 Qume Dr. San Jose, CA 95131 US Other 510(k) Applications for this Company
Contact	Li Zhou 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	04/03/2017
Decision Date	07/03/2017
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