510(k) K142422 ยท OZN C. Difficile Toxin Gene Amplification Assay
cobas Cdiff Test
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, May 20, 2015 |
| Received | Aug 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142422
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.