FDA 510(k) Application Details - K230828

Device Classification Name	More FDA Info for this Device
510(K) Number	K230828
Device Name	Flowflex COVID-19 Antigen Home Test
Applicant	ACON Laboratories, Inc. 5850 Oberlin Drive, #340 San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Qiyi Xie Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/27/2023
Decision Date	11/09/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review