510(k) K982622 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
EL-ANA PROFILES: EL-ENA/5
| Applicant | Theratest Laboratories, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Aug 13, 1998 |
| Received | Jun 18, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982622
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.