510(k) K813309 ยท DHR System, Test, Rheumatoid Factor
RA-80 POSITIVE CONTROL
| Applicant | Sun-Kit, Mchenry IL, US |
| Decision | Substantially Equivalent, Dec 17, 1981 |
| Received | Nov 24, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813309
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.