510(k) K913041 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ANTI-DSDNA ANTIBODY TEST
| Applicant | Helix Diagnostics, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Nov 5, 1991 |
| Received | Jul 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913041
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.