510(k) K932850 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN
| Applicant | Helix Diagnostics, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Sep 24, 1993 |
| Received | Jun 10, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932850
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.