510(k) K142826 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
ADVIA Centaur Toxoplasma M (Toxo M)
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 22, 2015 |
| Received | Sep 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142826
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.