510(k) K971989 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Oct 22, 1997 |
| Received | May 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971989
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.