FDA Product Code
FDA Product Code NQI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6020
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K130794 | CELLTRACKS ANALYZER II SYSTEM | Veridex, LLC | 2013-06-20 | Traditional | PDF ↗ |
| K122821 | CELLTRACKS AUTOPREP SYSTEM | Veridex, LLC | 2012-12-13 | Special | PDF ↗ |
| K110406 | CELLTRACKS AUTOPREP SYSTEM | Veridex, LLC | 2012-01-20 | Special | PDF ↗ |
| K113181 | CELLTRACKS ANALYER II | Veridex, LLC | 2011-12-12 | Special | PDF ↗ |
| K103502 | CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 | Veridex, LLC | 2010-12-21 | Special | PDF ↗ |
| K073338 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | 2008-02-26 | Traditional | PDF ↗ |
| K071729 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | 2007-11-20 | Traditional | PDF ↗ |
| K062013 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | 2006-12-14 | Traditional | PDF ↗ |
| K060110 | CELLTRACKS ANALYZER II | Immunicon Corp. | 2006-03-16 | Traditional | PDF ↗ |
| K052191 | MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | 2005-10-27 | Traditional | PDF ↗ |
| K050145 | CELLTRACKA ANALYZER II | Immunicon Corp. | 2005-03-15 | Traditional | PDF ↗ |
| K050245 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | 2005-03-15 | Traditional | PDF ↗ |
| DEN040001 | CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM | Advanced Diagnostic Systems | 2004-01-21 | Post-NSE | — |
Product code NQI · Class II · Immunology. Data: openFDA.