FDA 510(k) Application Details - K222563

Device Classification Name	More FDA Info for this Device
510(K) Number	K222563
Device Name	BD Kiestra IdentifA
Applicant	Becton, Dickinson and Company 7 Loveton Circle Mail Code 694 Sparks, MD 21152 US Other 510(k) Applications for this Company
Contact	Laura Stewart Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2022
Decision Date	08/31/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review