510(k) K992041 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
| Applicant | Immuno Concepts, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Jul 23, 1999 |
| Received | Jun 17, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992041
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.