510(k) K981498 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
IS-TOXOPLASMA IGG TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Aug 21, 1998 |
| Received | Apr 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981498
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.