510(k) K040077 ยท GKH Apparatus, Automated Blood Cell Diluting
IMMUNICON CELLTRACKS AUTOPREP SYSTEM
| Applicant | Immunicon Corp., Huntingdon Valley PA, US |
| Decision | Substantially Equivalent, Mar 12, 2004 |
| Received | Jan 14, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040077
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2010 | Veridex, LLC CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD
Veridex, LLC
a Johnson & Johnson Company
Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in Terminated |
GKH | None listed |
| Aug 13, 2009 | Veridex, LLC CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by Veridex, 33 Technology Drive, Warren, NJ 07059. Manufactured by Immunicon, Huntingdon Valley, Terminated |
GKH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.