510(k) Report

Devices descending from K033036

4 later devices reach BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240403Access BR MonitorBeckman Coulter, Inc.20240—
+1K072612Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and 387647Beckman Coulter, Inc.200731
+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