510(k) Report

Devices descending from K964703

6 later devices reach The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013984Immulite BR-MA, Model #LKBR; Immulite 2000 BR-MA, Model #L2KBRDiagnostic Products Corp.200212
+1K012357CA 15-3 Assay for the Advia Centaur SystemBayer Diagnostics Corp.20023—
+2K233946Immulite® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd.20240—
+2K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc.20190—
+2K100344Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator…Siemens Healthcare Diagnostics201111
+3K122398Rapidpoint 500 System Measurement Cartridge with CalibratorsSiemens Healthcare Diagnostics, Inc.201204