510(k) Report

Devices descending from K010962

1 later device reach Emit II Plus Methadone Assay, Model OSRE229 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062637Vitros Chemistry Products Metd Reagent, Calibrator Kit 26, Dat Performance, Verifiers I…Ortho-Clinical Diagnostics, Inc.20060—