510(k) K982281 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
SERAQUEST RUBELLA IGM
| Applicant | Quest Intl., Inc., North Miami FL, US |
| Decision | Substantially Equivalent, Oct 16, 1998 |
| Received | Jun 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982281
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.