ClearanceBrief
510(k) DEN240029 ยท SCA Multi-Analyte Respiratory Virus Antigen Detection Test

Healgen Rapid Check COVID-19/Flu A&B Antigen Test

ApplicantHealgen, Houston TX, US
DecisionUnknown, Oct 7, 2024
ReceivedJun 7, 2024
TypeDirect
FDA recordOpen on fda.gov

Recalls that name DEN240029

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.