510(k) K073338 ยท NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
CELLSEARCH CIRCULATING TUMOR CELL KIT
| Applicant | Veridex, LLC, Raritan NJ, US |
| Decision | Substantially Equivalent, Feb 26, 2008 |
| Received | Nov 28, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073338
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2010 | Veridex, LLC CellSearch Circulating Tumor Cell Kit (Epithelial) IVD
REF 7900001
Veridex LLC, a Johnson & Johnson Company. Terminated |
NQI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.