510(k) K891393 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT
| Applicant | Orgenics, Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Jun 23, 1989 |
| Received | Mar 14, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891393
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.