510(k) K083412 ยท DCN System, Test, C-Reactive Protein
PATHFAST HSCRP
| Applicant | Mitsubishi Kagaku Iatron, Seattle WA, US |
| Decision | Substantially Equivalent, Mar 9, 2009 |
| Received | Nov 18, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083412
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.