510(k) K130794 ยท NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
CELLTRACKS ANALYZER II SYSTEM
| Applicant | Veridex, LLC, Raritan NJ, US |
| Decision | Substantially Equivalent, Jun 20, 2013 |
| Received | Mar 22, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130794
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.