510(k) Report

Devices descending from K970894

2 later devices reach Vitros Immunodiagnostics Products Total B-HCG Reagent Pack (Gem.1075), Total… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063720Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators, Range VerifiersOrtho-Clinical Diagnostics200711
+2K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics20240—