ClearanceBrief
510(k) K243262 ยท SCA Multi-Analyte Respiratory Virus Antigen Detection Test

QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test

ApplicantOsang, LLC, Pasadena CA, US
DecisionSubstantially Equivalent, Jan 13, 2025
ReceivedOct 15, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K243262

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.