510(k) K210385 ยท OZN C. Difficile Toxin Gene Amplification Assay
cobas Cdiff nucleic acid test for use on the cobas Liat System
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Sep 9, 2021 |
| Received | Feb 9, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210385
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.