510(k) K163085 ยท OZN C. Difficile Toxin Gene Amplification Assay
Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack
| Applicant | Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC, Cypress CA, US |
| Decision | Substantially Equivalent, Feb 14, 2017 |
| Received | Nov 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163085
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.