510(k) K101946 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
VIDAS TOXO IGG AVIDITY
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, May 18, 2011 |
| Received | Jul 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101946
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2018 | BioMerieux SA VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium Terminated |
LGD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.