510(k) Report

Devices descending from K851202

3 later devices reach Gilford Tri-Level Assayed Immunology Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984045RF Control for Immunoturbidimetric AssaysKamiya Biomedical Co.19990—
+1K983130Liquid Immunology Controls for Immunoturbidimetric AssaysKamiya Biomedical Co.19980—
+1K983241Aso/CRP/RF Controls for Immunoturbidimetric AssaysKamiya Biomedical Co.19980—