510(k) K010147 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ENA EIA KIT
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Mar 1, 2001 |
| Received | Jan 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010147
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.