FDA 510(k) Application Details - K243256

Device Classification Name	More FDA Info for this Device
510(K) Number	K243256
Device Name	WELLlifeÖ COVID-19 / Influenza A&B Home Test; WELLlifeÖ COVID-19 / Influenza A&B AntigenTest
Applicant	Wondfo USA Co., Ltd. 6720 Cobra Way San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Kaiyu Xiao Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SCA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2024
Decision Date	01/16/2025
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