510(k) K030929 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ANA DETECT
| Applicant | Orgentec Diagnostika GmbH, Minneapolis MN, US |
| Decision | Substantially Equivalent, May 2, 2003 |
| Received | Mar 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030929
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.