510(k) Report

Devices descending from K963926

7 later devices reach Axsym CA 15-3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042732Architect CA 15-3 AssayFujirebio Diagnostics,Inc.20041—
+1K033036BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620…Beckman Coulter, Inc.200441
+2K240403Access BR MonitorBeckman Coulter, Inc.20240—
+2K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc.20200—
+2K072612Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and 387647Beckman Coulter, Inc.200731
+3K100344Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator…Siemens Healthcare Diagnostics201111
+4K122398Rapidpoint 500 System Measurement Cartridge with CalibratorsSiemens Healthcare Diagnostics, Inc.201204