510(k) Report

Devices descending from K012287

2 later devices reach Modification to: Cobas Integra LDL-Cholesterol Plus 2ND Generation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc.20110—
+1K032936Direct LDL Cholesterol Liquid Color and Stanbio Direct HDL/LDL Cholesterol CalibratorStanbio Laboratory20040—