510(k) K844743 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
SERATEST ENA(RNP/SM) DETERMINATION
| Applicant | Seragen Diagnostics, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 4, 1985 |
| Received | Dec 5, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K844743
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.