510(k) Report

Devices descending from K003341

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043384Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers…Ortho-Clinical Diagnostics, Inc.20050—