510(k) K110203 ยท OMN C. Difficile Nucleic Acid Amplification Test Assay
XPERT C. DIFFICLE/EPI ASSAY
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 7, 2011 |
| Received | Jan 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110203
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.