FDA.reportPublic FDA data

510(k) DEN040001

Device
CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM
Applicant
Advanced Diagnostic Systems
510(k) number
DEN040001
Product code
NQI
Decision
Unknown (DENG)
Decision date
2004-01-21
Date received
2004-01-02
Regulation
866.6020
Classification name
System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Post-NSE
Third party reviewed
N

Applicant Contact#

Contact
DEBRA J RASMUSSEN
Address
1001 U.S. Hwy. 202 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
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
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