510(k) K931495 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT
| Applicant | Helix Diagnostics, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Jul 16, 1993 |
| Received | Mar 25, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931495
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.