510(k) K132235 ยท OZN C. Difficile Toxin Gene Amplification Assay
IMDX C.DIFFICILE FOR ABBOTT M2000
| Applicant | Intelligent Medical Devices, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Oct 11, 2013 |
| Received | Jul 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132235
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.