510(k) Report

Devices descending from K063720

1 later device reach Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics20240—