510(k) K090847 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
PLATELIA TOXO IGM KIT MODEL 26211
| Applicant | Bio-Rad Laboratories, Redmond WA, US |
| Decision | Substantially Equivalent, Jul 1, 2009 |
| Received | Mar 30, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090847
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2025 | Bio-Rad Laboratories, Inc. Platelia Toxo IgM Catalog Number 26211
UDI Code: 03610520005552
The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplas Open, Classified |
LGD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.