510(k) K891081 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
CMV ELISA TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Jun 2, 1989 |
| Received | Mar 1, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891081
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2003 | Zeus Scientific Inc Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ. Terminated |
LFZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.