ClearanceBrief
510(k) K243406 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test

ApplicantRoche Molecular Systems, Inc., Pleasanton CA, US
DecisionSubstantially Equivalent, Apr 25, 2025
ReceivedNov 1, 2024
TypeDual Track
FDA recordOpen on fda.gov

Recalls that name K243406

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.