510(k) Report

Devices descending from K020845

1 later device reach Emit 2000 Vancomycin Calibrators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043386Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers…Ortho-Clinical Diagnostics, Inc.200503