510(k) K113181 ยท NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
CELLTRACKS ANALYER II
| Applicant | Veridex, LLC, Raritan NJ, US |
| Decision | Substantially Equivalent, Dec 12, 2011 |
| Received | Oct 28, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113181
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2012 | Veridex, LLC CellTracks Analyzer II.
A semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic Terminated |
NQI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.