510(k) K060201 ยท DHR System, Test, Rheumatoid Factor
OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.
| Applicant | Olympus America, Inc., Irving TX, US |
| Decision | Substantially Equivalent, Jun 6, 2006 |
| Received | Jan 26, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060201
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.