FDA 510(k) Application Details - K232377

Device Classification Name	More FDA Info for this Device
510(K) Number	K232377
Device Name	Healgen Rapid COVID-19 Antigen Test
Applicant	Healgen Scientific LLC 3818 Fuqua Street Houston, TX 77047 US Other 510(k) Applications for this Company
Contact	Jinjie Hu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2023
Decision Date	04/19/2024
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