FDA 510(k) Application Details - K182001

Device Classification Name	More FDA Info for this Device
510(K) Number	K182001
Device Name	Acucy Influenza A&B Test with the Acucy System
Applicant	Sekisui Diagnostics, LLC 6659 Top Gun St. San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Shelly Harris 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	07/26/2018
Decision Date	12/17/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review