510(k) K062013 ยท NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
CELLSEARCH CIRCULATING TUMOR CELL KIT
| Applicant | Veridex, LLC, Warren NJ, US |
| Decision | Substantially Equivalent, Dec 14, 2006 |
| Received | Jul 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062013
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2007 | Veridex, LLC Cell Search Circulating Tumor Cell Kit (Epithelial)
Veridex LLC, a Johnson & Johnson Company
IVD
Veridex, LLC
33 Technology Drive
Warren, NJ 07059 USA
1-877-VERIDEX USA Terminated |
NQI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.