ClearanceBrief
510(k) K261336 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Xpert Respiratory Panel

ApplicantCepheid, Sunnyvale CA, US
DecisionSubstantially Equivalent, Sep 25, 2026
ReceivedApr 23, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K261336

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.