510(k) K905194 ยท LKO Anti-Rnp Antibody, Antigen And Control
DIASTAT ANTI-RO (SS-A)
| Applicant | Shield Diagnostics, Ltd., Scotland, KN |
| Decision | Substantially Equivalent, Dec 13, 1990 |
| Received | Nov 19, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905194
| 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 autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrate Terminated |
LKO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.