510(k) K001900 ยท LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
| Applicant | Helix Diagnostics, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Sep 11, 2000 |
| Received | Jun 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001900
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.