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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Respiratory Virus Antigen Detection Test
510(k) Number K243262
Device Name QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test
Applicant
Osang LLC
215 N. Marengo Ave. 3rd Fl.
Pasadena,  CA  91101
Applicant Contact Seungyeob (Dan) Lee
Correspondent
Hyman, Phelps and McNamara, P.C.
700 Thirteenth Street, N.W.
Suite 1200
Washington,  DC  20005 -5929
Correspondent Contact Lisa Baumhardt
Classification Product Code
SCA  
Date Received10/15/2024
Decision Date 01/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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