510(k) K980337 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
| Applicant | Helix Diagnostics, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, May 12, 1998 |
| Received | Jan 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980337
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.