ClearanceBrief
510(k) K261212 ยท SCA Multi-Analyte Respiratory Virus Antigen Detection Test

Flowflex Plus RSV + Flu A/B + COVID Rapid Test

ApplicantACON Laboratories, Inc., San Diego CA, US
DecisionSubstantially Equivalent, Jul 10, 2026
ReceivedApr 14, 2026
TypeDual Track
FDA recordOpen on fda.gov

Recalls that name K261212

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.