510(k) K004019 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ANA EIA DIAGNOSTIC TEST KIT
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Feb 15, 2001 |
| Received | Dec 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K004019
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.