510(k) K122821 ยท NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
CELLTRACKS AUTOPREP SYSTEM
| Applicant | Veridex, LLC, Raritan NJ, US |
| Decision | Substantially Equivalent, Dec 13, 2012 |
| Received | Sep 14, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122821
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2013 | Veridex, LLC CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below.
Product Usage:
The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture a Terminated |
NQI | None listed |
| Aug 10, 2013 | Veridex, LLC CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below.
Product Usage:
The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and e Terminated |
NQI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.