FDA 510(k) Application Details - K213280

Device Classification Name	More FDA Info for this Device
510(K) Number	K213280
Device Name	BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
Applicant	BD Kiestra B.V. Marconilaan 6 Drachten 9207 JC NL Other 510(k) Applications for this Company
Contact	Karin Brands Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2021
Decision Date	05/04/2023
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