510(k) K081920 ยท LLH Reagents, Clostridium Difficile Toxin
BD GENEOHM CDIFF ASSAY
| Applicant | Bd Diagnostics (Geneohm Sciences, Inc.), San Diego CA, US |
| Decision | Substantially Equivalent, Dec 19, 2008 |
| Received | Jul 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081920
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2014 | Becton Dickinson & Co. BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5 Terminated |
LLH | None listed |
| Sep 6, 2012 | Becton Dickinson & Co. BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***
BD GeneOhm Cdiff Assay is a qualitative i Terminated |
LLH | None listed |
| Sep 6, 2012 | Becton Dickinson & Co. BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***
BD GeneOhm Cdiff Assay Terminated |
LLH | None listed |
| Aug 5, 2010 | Becton Dickinson & Co. BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, 2555 Boul. Du Parc-Technologique, Quebec, Canada G1P4S5***
Intended for use as an aid in diagnosis of CDAD. Terminated |
LLH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.