510(k) Report

Devices descending from K061588

1 later device reach Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…Ortho-Clinical Diagnostics, Inc.20130—