510(k) Report

Devices descending from K904768

16 later devices reach Kodatrol I and II Control and Diluent Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042006Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator Kit 25…Ortho-Clinical Diagnostics, Inc.200423
+1K041764The Vitros 5,1 FS Chemistry SystemOrtho-Clinical Diagnostics20044—
+1K041720Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and…Ortho-Clinical Diagnostics, Inc.200471
+2K142595VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry…Ortho Clinical Diagnostics201502
+2K120609Vitros Chemistry Products DHDL SlidesOrtho-Clinical Diagnostics, Inc.201201
+2K081895Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C CalibratorsSiemens Medical Solutions Diagnostics200912
+2K060650Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc.20060—
+2K052867Vitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc.200501
+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—
+3K110934Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment AssaySiemens Healthcare Diagnostics201102
+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—