510(k) Report

Devices descending from DEN040001

10 later devices reach Cellsearch Epithelial Cell Enrichment Kit; Cellspotter System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050145Celltracka Analyzer IIImmunicon Corp.200532
+1K050245Cellsearch Circulating Tumor Cell KitVeridex, LLC200541
+1K040898Cellsearch Epithelial Cell Control KitVeridex, LLC200401
+2K062013Cellsearch Circulating Tumor Cell KitVeridex, LLC200631
+2K060110Celltracks Analyzer IIImmunicon Corp.200621
+3K113181Celltracks Analyer IIVeridex, LLC201111
+3K071729Cellsearch Circulating Tumor Cell KitVeridex, LLC20072—
+4K130794Celltracks Analyzer II SystemVeridex, LLC201301
+4K073338Cellsearch Circulating Tumor Cell KitVeridex, LLC200811
+5K103502Cellsearch Circulating Tumor Cell Kit Model 7900001Veridex, LLC201003