510(k) K200065 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Feb 10, 2020 |
| Received | Jan 13, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200065
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.