510(k) K052191 ยท NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT
| Applicant | Veridex, LLC, Raritan NJ, US |
| Decision | Substantially Equivalent, Oct 27, 2005 |
| Received | Aug 11, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052191
| 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.