510(k) K242095 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Access Toxo IgM II
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Oct 11, 2024 |
| Received | Jul 17, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242095
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.