510(k) K001574 ยท MID System, Test, Anticardiolipin Immunological
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
| Applicant | Axis-Shield, Dundee Tayside, Scotland, GB |
| Decision | Substantially Equivalent, Jun 9, 2000 |
| Received | May 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001574
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2018 | Euro Diagnostica AB is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium hepar Terminated |
MID | None listed |
| Aug 23, 2018 | Euro Diagnostica AB is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium hepar Terminated |
MID | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.