CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM
FDA 510(k) clearance DEN040001 · decided 2004-01-21
Clearance details
- K-number
- DEN040001
- Device name
- CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM
- Applicant
- Advanced Diagnostic Systems
- Decision
- Unknown
- Date received
- 2004-01-02
- Decision date
- 2004-01-21
- Days to decision
- 19 days
- Clearance type
- Post-NSE
- Product code
- NQI
- Device class
- 2
- Regulation number
- 866.6020
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Raritan, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CELLTRACKS ANALYZER II SYSTEM (K130794) | Veridex, LLC | 2013-06-20 |
| CELLTRACKS AUTOPREP SYSTEM (K122821) | Veridex, LLC | 2012-12-13 |
| CELLTRACKS AUTOPREP SYSTEM (K110406) | Veridex, LLC | 2012-01-20 |
| CELLTRACKS ANALYER II (K113181) | Veridex, LLC | 2011-12-12 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 (K103502) | Veridex, LLC | 2010-12-21 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K073338) | Veridex, LLC | 2008-02-26 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K071729) | Veridex, LLC | 2007-11-20 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K062013) | Veridex, LLC | 2006-12-14 |
| CELLTRACKS ANALYZER II (K060110) | Immunicon Corp. | 2006-03-16 |
| MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT (K052191) | Veridex, LLC | 2005-10-27 |
| CELLTRACKA ANALYZER II (K050145) | Immunicon Corp. | 2005-03-15 |
| CELLSEARCH CIRCULATING TUMOR CELL KIT (K050245) | Veridex, LLC | 2005-03-15 |
Recalls involving this device
No recalls on record reference this clearance.