510(k) Report

Devices descending from DEN040008

6 later devices reach Cedia Sirolimus Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100144Thermo Scientific QMS Everolimus Reagents, Calibrators and ControlsMicrogenics Corp.20111—
+1K042411Abbott Imx Sirolimus Microparticle Enzyme ImmunoassayAxis-Shield, Ltd.200532
+2K122766Thermo Scientific QMS Everolimus AssayMicrogenics Corp.201301
+2K083487Emit 2000 Sirolimus Assay, Emit 2000 Siro/Tacro Sample Pretreatment Reagent, and Emit…Siemens Healthcare Diagnostics200901
+2K081857Dimension Siro Flex Reagent Cartridge and Dimension Sirolimus Calbirator, Models DR 306…Siemens Healthcare Diagnostics, Inc.200802
+2K070822Architect Sirolimus AssayFujirebio Diagnostics,Inc.200702