510(k) Report

Devices descending from K012357

3 later devices reach CA 15-3 Assay for the Advia Centaur System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc.20190—
+1K100344Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator…Siemens Healthcare Diagnostics201111
+2K122398Rapidpoint 500 System Measurement Cartridge with CalibratorsSiemens Healthcare Diagnostics, Inc.201204