510(k) Report

Devices descending from K140818

3 later devices reach Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…Siemens Healthcare Diagnostics, Inc.20150—
+1K143636IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin…Siemens Healthcare Diagnostics, Inc.20150—
+1K143352IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3…Siemens Healthcare Diagnostics, Inc.20140—