Panels › Immunology › Product code NQI · Class 2
System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Regulation 866.6020
0510(k)s in 12 months (13 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in NQI
| Company | 510(k)s | Recalls |
|---|---|---|
| Veridex, LLC | 10 | 7 |
| Immunicon Corp. | 2 | 0 |
| Menarini Silicon Biosystems | 0 | 2 |
| Advanced Diagnostic Systems | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2013 | K130794 | CELLTRACKS ANALYZER II SYSTEM Veridex, LLC | NQI |
| Dec 13, 2012 | K122821 | CELLTRACKS AUTOPREP SYSTEM Veridex, LLC | NQI |
| Jan 20, 2012 | K110406 | CELLTRACKS AUTOPREP SYSTEM Veridex, LLC | NQI |
| Dec 12, 2011 | K113181 | CELLTRACKS ANALYER II Veridex, LLC | NQI |
| Dec 21, 2010 | K103502 | CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 Veridex, LLC | NQI |
| Feb 26, 2008 | K073338 | CELLSEARCH CIRCULATING TUMOR CELL KIT Veridex, LLC | NQI |
| Nov 20, 2007 | K071729 | CELLSEARCH CIRCULATING TUMOR CELL KIT Veridex, LLC | NQI |
| Dec 14, 2006 | K062013 | CELLSEARCH CIRCULATING TUMOR CELL KIT Veridex, LLC | NQI |
| Mar 16, 2006 | K060110 | CELLTRACKS ANALYZER II Immunicon Corp. | NQI |
| Oct 27, 2005 | K052191 | MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT Veridex, LLC | NQI |
| Mar 15, 2005 | K050245 | CELLSEARCH CIRCULATING TUMOR CELL KIT Veridex, LLC | NQI |
| Mar 15, 2005 | K050145 | CELLTRACKA ANALYZER II Immunicon Corp. | NQI |
| Jan 21, 2004 | DEN040001 | CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM Advanced Diagnostic Systems | NQI |
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