510(k) K133936 ยท OZN C. Difficile Toxin Gene Amplification Assay
ARTUS C. DIFFICILE QS-RGQ MDX KIT
| Applicant | QIAGEN GmbH, Gaithersburg MD, US |
| Decision | Substantially Equivalent, Apr 4, 2014 |
| Received | Dec 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133936
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.