510(k) K103502 ยท NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001
| Applicant | Veridex, LLC, Raritan NJ, US |
| Decision | Substantially Equivalent, Dec 21, 2010 |
| Received | Nov 29, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103502
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2022 | Menarini Silicon Biosystems CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole Open, Classified |
NQI | None listed |
| Apr 4, 2018 | Menarini Silicon Biosystems CELLSEARCH CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001)
CELLSEARCH CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD Terminated |
NQI | None listed |
| Aug 18, 2015 | Veridex, LLC Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood. Terminated |
NQI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.