510(k) Report

Devices descending from K102269

2 later devices reach Elecsys Ige Calcheck 5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133122Immulite 2000; 3GALLERGY Specific Ige Control Verification Material (CVM), Total Ige…Siemens Healthcare Diagnostics, Inc.20131—
+2K143680ADVIA Centaur IgE Master Curve MaterialSiemens Healthcare Diagnostics, Inc.20150—