510(k) Report

Devices descending from K963213

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012286Modification to:Cobas Integra HDL-Cholesterol Plus 2ND GenerationRoche Diagnostics Corp.200112
+1K982767Raichem HDL-Cholesterol Direct Reagent, HDL-Cholesterol CalibratorRaichem19980—
+1K981580HDLAbbott Laboratories199801
+2K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings20180—