510(k) K980540 ยท LKP Anti-Sm Antibody, Antigen And Control
SERAQUEST ANTI-SM
| Applicant | Quest Intl., Inc., North Miami FL, US |
| Decision | Substantially Equivalent, Jun 15, 1998 |
| Received | Feb 12, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980540
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.