510(k) K182747 ยท DHR System, Test, Rheumatoid Factor
EliA RF IgM Immunoassay
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Dec 18, 2018 |
| Received | Sep 28, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182747
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2019 | Phadia Ab EliA RF IgM Well, REF 14-5600-01
Product Usage: Usage:
EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-hepar Terminated |
DHR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.