510(k) K022018 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
| Applicant | Rhigene, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, Jul 5, 2002 |
| Received | Jun 20, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022018
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.