510(k) K885344 ยท LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT
| Applicant | Orgenics, Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Apr 12, 1989 |
| Received | Dec 28, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885344
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.