510(k) K932876 ยท LKJ Antinuclear Antibody, Antigen, Control
DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT
| Applicant | Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Nov 15, 1993 |
| Received | Jun 14, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932876
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2017 | Euro Diagnostica AB Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA
DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definit Terminated |
LKJ | None listed |
| May 22, 2017 | Euro Diagnostica AB DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human s Terminated |
LKJ | None listed |
| Oct 15, 2015 | Euro Diagnostica AB DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200.
Product Usage:
The DIASTAT anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA Terminated |
LKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.