510(k) Report

Devices descending from K972133

2 later devices reach Vitros Immunodiagnostics Products Progesterone Reagent Pack (Gem.1070)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022901Vitros Immunodiagnostic Products Progesterone Reagent Pack and CalibratorsOrtho-Clinical Diagnostics20021—
+2K032296Vitros Immunodiagnostic Products Progestrone Reagent Pack and CalibratorsOrtho-Clinical Diagnostics, Inc.20030—