510(k) K913731 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
ENZYGNOST(R) TOXOPLASMOSIS/IGG
| Applicant | Behring Diagnostics, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Apr 29, 1992 |
| Received | Aug 20, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913731
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.