FDA 510(k) Application Details - K191964

Device Classification Name	More FDA Info for this Device
510(K) Number	K191964
Device Name	BD Kiestra IdentifA
Applicant	Becton, Dickinson and Company 7 Loveton Circle, MC 964 Sparks, MD 21152 US Other 510(k) Applications for this Company
Contact	Janine Spafford 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	07/23/2019
Decision Date	11/03/2021
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