510(k) K943291 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ANTI DS-DNA
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Dec 2, 1994 |
| Received | Jul 8, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943291
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.