510(k) K260045 · OZN C. Difficile Toxin Gene Amplification Assay
cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Aug 28, 2026 |
| Received | Jan 7, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260045
No recall in the FDA data names this 510(k).
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