510(k) K905190 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
DIASTAT ENA PROFILE
| Applicant | Shield Diagnostics, Ltd., Scotland, KN |
| Decision | Substantially Equivalent, Dec 7, 1990 |
| Received | Nov 19, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905190
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.