510(k) K173792 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Mar 13, 2018 |
| Received | Dec 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173792
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2024 | Phadia Ab EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic Open, Classified |
MOB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.