510(k) K012183 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY
| Applicant | Bayer Diagnostics Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Dec 27, 2001 |
| Received | Jul 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012183
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.