510(k) K051066 ยท LKP Anti-Sm Antibody, Antigen And Control
THERATEST EL-ANA PROFILES
| Applicant | Theratest Laboratories, Inc., Lombard IL, US |
| Decision | Substantially Equivalent, Oct 7, 2005 |
| Received | Apr 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051066
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.