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510(k) K110406

Device
CELLTRACKS AUTOPREP SYSTEM
Applicant
VERIDEX, LLC
510(k) number
K110406
Product code
NQI  
Decision
Substantially Equivalent (SESE)
Decision date
2012-01-20
Date received
2011-02-14
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
JESSICA SHELFFO
Address
1001 U.S. Hwy. 202 N. Raritan NJ US 08869 08869

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NQI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K130794CELLTRACKS ANALYZER II SYSTEMVeridex, LLC2013-06-20
K122821CELLTRACKS AUTOPREP SYSTEMVeridex, LLC2012-12-13
K113181CELLTRACKS ANALYER IIVeridex, LLC2011-12-12
K103502CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001Veridex, LLC2010-12-21
K073338CELLSEARCH CIRCULATING TUMOR CELL KITVeridex, LLC2008-02-26
K071729CELLSEARCH CIRCULATING TUMOR CELL KITVeridex, LLC2007-11-20
K062013CELLSEARCH CIRCULATING TUMOR CELL KITVeridex, LLC2006-12-14
K060110CELLTRACKS ANALYZER IIImmunicon Corp.2006-03-16
K052191MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KITVeridex, LLC2005-10-27
K050145CELLTRACKA ANALYZER IIImmunicon Corp.2005-03-15
K050245CELLSEARCH CIRCULATING TUMOR CELL KITVeridex, LLC2005-03-15
DEN040001CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEMAdvanced Diagnostic Systems2004-01-21

Legacy Summary#

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FDA Review#

Decision Summary