510(k) K001556 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Aug 21, 2000 |
| Received | May 18, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001556
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.