510(k) K223783 ยท QWR Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Dec 4, 2023 |
| Received | Dec 16, 2022 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K223783
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.