510(k) K102673 ยท DHR System, Test, Rheumatoid Factor
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
| Applicant | Phadia US, Inc., Portage MI, US |
| Decision | Substantially Equivalent, Sep 30, 2011 |
| Received | Sep 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102673
| 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.