510(k) Report

Devices descending from K881040

3 later devices reach Emit Vancomycin Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020692Emit 2000 Vancomycin AssayDade Behring, Inc.20021—
+1K020845Emit 2000 Vancomycin CalibratorsDade Behring, Inc.20021—
+2K043386Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers…Ortho-Clinical Diagnostics, Inc.200503