Atlas FDA

CELLSEARCH CIRCULATING TUMOR CELL KIT

FDA 510(k) clearance K050245 · decided 2005-03-15

Clearance details

K-number
K050245
Device name
CELLSEARCH CIRCULATING TUMOR CELL KIT
Applicant
Veridex, LLC
Decision
Substantially Equivalent
Date received
2005-02-02
Decision date
2005-03-15
Days to decision
41 days
Clearance type
Traditional
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.

RecordFirmDate
CELLTRACKS ANALYZER II SYSTEM (K130794)Veridex, LLC2013-06-20
CELLTRACKS AUTOPREP SYSTEM (K122821)Veridex, LLC2012-12-13
CELLTRACKS AUTOPREP SYSTEM (K110406)Veridex, LLC2012-01-20
CELLTRACKS ANALYER II (K113181)Veridex, LLC2011-12-12
CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 (K103502)Veridex, LLC2010-12-21
CELLSEARCH CIRCULATING TUMOR CELL KIT (K073338)Veridex, LLC2008-02-26
CELLSEARCH CIRCULATING TUMOR CELL KIT (K071729)Veridex, LLC2007-11-20
CELLSEARCH CIRCULATING TUMOR CELL KIT (K062013)Veridex, LLC2006-12-14
CELLTRACKS ANALYZER II (K060110)Immunicon Corp.2006-03-16
MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT (K052191)Veridex, LLC2005-10-27
CELLTRACKA ANALYZER II (K050145)Immunicon Corp.2005-03-15
CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM (DEN040001)Advanced Diagnostic Systems2004-01-21

Recalls involving this device

RecordFirmDate
Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC, a Johnson & Johnson Compa recall (Z-1102-2007)Veridex, LLC2007-07-24