510(k) K100499 ยท DHR System, Test, Rheumatoid Factor
ORGENTEC RHEUMATOID FACTOR EIA
| Applicant | Orgentec Diagnostika GmbH, East Stroudsburg PA, US |
| Decision | Substantially Equivalent, Oct 27, 2010 |
| Received | Feb 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100499
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.