510(k) Report

Devices descending from K052788

4 later devices reach N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/H through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110874Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin CalibratorSiemens Healthcare Diagnostics, Inc.20120—
+1K083463Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension…Siemens Healthcare Diagnostics200904
+1K063206Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control…Dade Behring, Inc.200613
+2K062105Diazyme Creatinine Liquid Reagents AssayDiazyme Laboratories20070—