510(k) K141133 ยท LYR Helicobacter Pylori
VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II
| Applicant | BIOMERIEUX, Hazelwood MO, US |
| Decision | Substantially Equivalent, Jul 9, 2015 |
| Received | May 1, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141133
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226 Open, Classified |
LYR | None listed |
| Jan 4, 2023 | Biomerieux Inc VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01 Open, Classified |
LYR | None listed |
| Sep 22, 2021 | bioMerieux, Inc. VIDAS DEX@, Dimer Exclusion II, REF 30455-01 Open, Classified |
DAP | None listed |
| Oct 22, 2019 | Biomerieux Inc BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.