510(k) Report

Devices descending from K833402

2 later devices reach Tech. RA-1000SYS-Analytes Immunoglobulin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033791Bayer Specific Protein Reference SerumBayer Healthcare, LLC20041—
+2K063150Complement C3 and C4, Specical Calibrator and Specitrol Control and High ControlThermo Electron OY20070—