510(k) K894948 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
PLATELIA TOXO IGM KIT
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Mar 15, 1990 |
| Received | Aug 3, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894948
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.