510(k) Report

Devices descending from K974733

5 later devices reach Boehringer Mannheim Direct LDL - Cholesterol through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143691LDLC3 LDL-Cholesterol Gen.3Roche Diagnostics Operations (Rdo)20150—
+1K040693PTS Panels LDL Cholesterol Test StripsPolymer Technology Systems, Inc.200401
+1K012287Modification to: Cobas Integra LDL-Cholesterol Plus 2ND GenerationRoche Diagnostics Corp.200122
+2K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc.20110—
+2K032936Direct LDL Cholesterol Liquid Color and Stanbio Direct HDL/LDL Cholesterol CalibratorStanbio Laboratory20040—