510(k) K103502
- Device
- CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001
- Applicant
- VERIDEX, LLC
- 510(k) number
- K103502
- Product code
- NQI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-12-21
- Date received
- 2010-11-29
- Regulation
- 866.6020
- Classification name
- System, Immunomagnetic, Circulating Cancer Cell, Enumeration
- Medical specialty
- Immunology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SARAH MCMANUS
- Address
- 1001 U.S. Hwy. 202 N. Raritan NJ US 08869 08869
FDA Registration Numbers#
- 3003144120
- 3004153557
- 1938173
Source Documents#
Other 510(k) Records For Product Code NQI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130794 | CELLTRACKS ANALYZER II SYSTEM | Veridex, LLC | 2013-06-20 |
| K122821 | CELLTRACKS AUTOPREP SYSTEM | Veridex, LLC | 2012-12-13 |
| K110406 | CELLTRACKS AUTOPREP SYSTEM | Veridex, LLC | 2012-01-20 |
| K113181 | CELLTRACKS ANALYER II | Veridex, LLC | 2011-12-12 |
| K073338 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | 2008-02-26 |
| K071729 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | 2007-11-20 |
| K062013 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | 2006-12-14 |
| K060110 | CELLTRACKS ANALYZER II | Immunicon Corp. | 2006-03-16 |
| K052191 | MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | 2005-10-27 |
| K050145 | CELLTRACKA ANALYZER II | Immunicon Corp. | 2005-03-15 |
| K050245 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Veridex, LLC | 2005-03-15 |
| DEN040001 | CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM | Advanced Diagnostic Systems | 2004-01-21 |
Legacy Summary#
summary
FDA Review#
Decision Summary