510(k) K971672 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
SERAQUEST TOXOPLASMA IGM
| Applicant | Quest Intl., Inc., North Miami FL, US |
| Decision | Substantially Equivalent, Oct 21, 1997 |
| Received | May 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971672
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.