510(k) K862216 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)
| Applicant | Labsystems, Inc., Morton Grove IL, US |
| Decision | Substantially Equivalent, Jun 30, 1986 |
| Received | Jun 10, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862216
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.