510(k) K920616 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
DIASTAT ANTI-HISTONE KIT
| Applicant | Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Jul 14, 1992 |
| Received | Feb 11, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920616
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.