510(k) K113433 ยท OMN C. Difficile Nucleic Acid Amplification Test Assay
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
| Applicant | Focus Diagnostics, Inc., Cypress CA, US |
| Decision | Substantially Equivalent, Apr 4, 2012 |
| Received | Nov 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113433
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.