510(k) Report

Devices descending from K981297

3 later devices reach Immulite OM-MA, Models Lkopz, LKOP1, LKOP5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213510Immulite/Immulite 1000 OM-MA, Immulite 2000 OM-MASiemens Healthcare Diagnostics Products, Ltd.20230—
+1K983391Immulite 2000 OM-MA Model L2KOP2Diagnostic Products Corp.199821
+2K072794Immulite 2500 OM-MA, Model L5KOPSiemens Medical Solutions Diagnostics20070—