FDA 510(k) Application Details - K241313

Device Classification Name	More FDA Info for this Device
510(K) Number	K241313
Device Name	OHC COVID-19 Antigen Self Test
Applicant	Osang LLC 215 N. Marengo Ave. 3rd Fl. Pasadena, CA 91101 US Other 510(k) Applications for this Company
Contact	Seungyeob Dan Lee 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	05/09/2024
Decision Date	05/30/2025
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