510(k) Report

Devices descending from K042411

3 later devices reach Abbott Imx Sirolimus Microparticle Enzyme Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083487Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment Reagent, and Emit…Siemens Healthcare Diagnostics200901
+1K081857Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models DR 306…Siemens Healthcare Diagnostics, Inc.200802
+1K070822Architect Sirolimus AssayFujirebio Diagnostics,Inc.200702