510(k) K050145 ยท NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
CELLTRACKA ANALYZER II
| Applicant | Immunicon Corp., Huntingdon Valley PA, US |
| Decision | Substantially Equivalent, Mar 15, 2005 |
| Received | Jan 24, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050145
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2014 | Veridex, LLC CELLTRACKS ANALYZER II (Product Code 9555)
Product Usage:
The CELLTRACKS ANALYZER II is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS sof Terminated |
NQI | None listed |
| 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.