510(k) K980391 ยท LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
SERAQUEST ANTI-DSDNA
| Applicant | Quest Intl., Inc., North Miami FL, US |
| Decision | Substantially Equivalent, Apr 24, 1998 |
| Received | Feb 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980391
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.