510(k) Report

Devices descending from K060359

1 later device reach Archiect Insulin and Controls, Model 8K41-01, 8K41-10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics20170—