510(k) K000489 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
| Applicant | Helix Diagnostics, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Apr 5, 2000 |
| Received | Feb 14, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000489
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.