FDA 510(k) Application Details - K222591

Device Classification Name	System, Blood Culturing   More FDA Info for this Device
510(K) Number	K222591
Device Name	System, Blood Culturing
Applicant	Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 US Other 510(k) Applications for this Company
Contact	Susan Kircher Other 510(k) Applications for this Contact
Regulation Number	866.2560   More FDA Info for this Regulation Number
Classification Product Code	MDB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2022
Decision Date	03/24/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review