510(k) K920661 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
VIDAS CMV IGG ASSAY
| Applicant | Vitek Systems, Inc., Hazelwood MI, US |
| Decision | Substantially Equivalent, Feb 12, 1993 |
| Received | Feb 13, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920661
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | bioMerieux VIDAS CMV IgG Assay Terminated |
LFZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.