510(k) K923122 ยท LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
| Applicant | Biomerieux Vitek, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Oct 26, 1992 |
| Received | Jun 26, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923122
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217 Open, Classified |
LFY | None listed |
| Dec 10, 2019 | bioMerieux, Inc. VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit Terminated |
LFY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.