510(k) K140225 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
| Applicant | Phadia US, Inc., Freiburg Im Breisgau, DE |
| Decision | Substantially Equivalent, Oct 27, 2014 |
| Received | Jan 29, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140225
| 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.