FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT
K Number: K052191
·
Decision Oct 27, 2005
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
12
Applicant Total
12
Review Days
77
Basic Information
- Device Name
- MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT
- K Number
- K052191
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6020
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- VERIDEX, LLC
- Date Received
- August 11, 2005
- Decision Date
- October 27, 2005
- Product Code
- NQI
- Advisory Committee
- Immunology
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NQI | System, Immunomagnetic, Circulating Cancer Cell, Enumeration | FDA class 2 | Immunology |
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Other Clearances by VERIDEX, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K130794 | CELLTRACKS ANALYZER II SYSTEM | Jun 20, 2013 | Substantially Equivalent |
| K122821 | CELLTRACKS AUTOPREP SYSTEM | Dec 13, 2012 | Substantially Equivalent |
| K110406 | CELLTRACKS AUTOPREP SYSTEM | Jan 20, 2012 | Substantially Equivalent |
| K113181 | CELLTRACKS ANALYER II | Dec 12, 2011 | Substantially Equivalent |
| K103502 | CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 | Dec 21, 2010 | Substantially Equivalent |
| K100684 | CELLTRACKS AUTOPREP SYSTEM MODEL:9541 | Aug 26, 2010 | Substantially Equivalent |
| K073338 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Feb 26, 2008 | Substantially Equivalent |
| K071729 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Nov 20, 2007 | Substantially Equivalent |
| K062013 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Dec 14, 2006 | Substantially Equivalent |
| K050245 | CELLSEARCH CIRCULATING TUMOR CELL KIT | Mar 15, 2005 | Substantially Equivalent |