510(k) K984045 ยท DHR System, Test, Rheumatoid Factor
RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS
| Applicant | Kamiya Biomedical Co., Seattle WA, US |
| Decision | Substantially Equivalent, Jan 25, 1999 |
| Received | Nov 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984045
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.