ClearanceBrief
510(k) K223591 · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System

ApplicantRoche Molecular Systems, Inc., Pleasanton CA, US
DecisionSubstantially Equivalent, Jul 27, 2023
ReceivedDec 1, 2022
TypeDual Track
FDA recordOpen on fda.gov

Recalls that name K223591

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.