FDA 510(k) Application Details - K180438

Device Classification Name	More FDA Info for this Device
510(K) Number	K180438
Device Name	BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
Applicant	BD 10865 Road to the Cure San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Brad Spring Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/2018
Decision Date	03/20/2018
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