510(k) Report

Devices descending from K052819

3 later devices reach Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061588Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy…Ortho-Clinical Diagnostics, Inc.200611
+1K060940Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT…Ortho-Clinical Diagnostics, Inc.20060—
+2K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…Ortho-Clinical Diagnostics, Inc.20130—