FDA 510(k) Application Details - DEN240029

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN240029
Device Name	Healgen Rapid Check COVID-19/Flu A&B Antigen Test
Applicant	Healgen 3818 Fuqua Street Houston, TX 77047 US Other 510(k) Applications for this Company
Contact	Bingliang Fang 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	06/07/2024
Decision Date	10/07/2024
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review