510(k) Report

Devices descending from K072612

3 later devices reach Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240403Access BR MonitorBeckman Coulter, Inc.20240—
+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