510(k) Report

Devices descending from K011289

1 later device reach Emit II Plus Opiate Assay, Model OSR9B229 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062460Vitros Chemistry Products OP Reagent, Calibrator Kit 26 and Dat Performance Verifiers I…Ortho-Clinical Diagnostics, Inc.200601