510(k) K994071 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
RHIGENE ANA ELISA TEST SYSTEM
| Applicant | Rhigene, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, Jan 18, 2000 |
| Received | Dec 2, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994071
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.