510(k) K912291 ยท LKJ Antinuclear Antibody, Antigen, Control
DISTAT ANTI-SCL-70 KIT
| Applicant | Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Jul 30, 1991 |
| Received | May 23, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912291
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2018 | Euro Diagnostica AB is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended Terminated |
LKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.