ClearanceBrief
510(k) K263120 · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Xpert Xpress CoV-2/Flu plus

ApplicantCepheid®, Sunnyvale CA, US
DecisionSubstantially Equivalent, Oct 2, 2026
ReceivedSep 4, 2026
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K263120

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.