510(k) K192727 ยท DHR System, Test, Rheumatoid Factor
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
| Applicant | Kamiya Biomedical Company, Tukwila WA, US |
| Decision | Substantially Equivalent, May 20, 2020 |
| Received | Sep 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192727
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.