510(k) Report

Devices descending from K962519

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042479Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products…Ortho-Clinical Diagnostics, Inc.200501