510(k) K010755 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY
| Applicant | Bayer Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Aug 20, 2001 |
| Received | Mar 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010755
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.