510(k) K951850 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT
| Applicant | Helix Diagnostics, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Jul 18, 1995 |
| Received | Apr 21, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951850
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.