510(k) Report

Devices descending from K020852

8 later devices reach Poly-Chem Glucose through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041720Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and…Ortho-Clinical Diagnostics, Inc.200471
+2K042477Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20…Ortho-Clinical Diagnostics, Inc.20044—
+2K042643Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance Verifiers I…Ortho-Clinical Diagnostics, Inc.200401
+2K042494Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance…Ortho-Clinical Diagnostics20040—
+3K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…Ortho-Clinical Diagnostics, Inc.20053—
+4K061588Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy…Ortho-Clinical Diagnostics, Inc.200611
+4K060940Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT…Ortho-Clinical Diagnostics, Inc.20060—
+5K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…Ortho-Clinical Diagnostics, Inc.20130—