510(k) K954301 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Mar 24, 1997 |
| Received | Aug 23, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954301
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.