FDA 510(k) Application Details - K241317

Device Classification Name	More FDA Info for this Device
510(K) Number	K241317
Device Name	Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
Applicant	Guangzhou Wondfo Biotech Co., Ltd. No.8 Lizhishan Road, Science City, Huangpu District Guangzhou 510663 CN Other 510(k) Applications for this Company
Contact	Xiao Kaiyu 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	05/10/2024
Decision Date	09/30/2024
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