FDA.reportPublic FDA data

510(k) K060110

Device
CELLTRACKS ANALYZER II
Applicant
IMMUNICON CORP.
510(k) number
K060110
Product code
NQI  
Decision
Substantially Equivalent (SESE)
Decision date
2006-03-16
Date received
2006-01-17
Regulation
866.6020
Classification name
System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Medical specialty
Immunology
Review panel
Pathology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PETER SCOTT
Address
3401 Masons Mill Rd. Suite 100 Huntingdon Valley PA US 19006 19006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K110406CELLTRACKS AUTOPREP SYSTEMVeridex, LLC2012-01-20
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
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#

summary

FDA Review#

Decision Summary