510(k) Report

Devices descending from K133124

5 later devices reach Immulite 2000; Total T3 Calibration Verification Material, Total T4… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…Siemens Healthcare Diagnostics, Inc.20150—
+1K141444Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration…Siemens Healthcare Diagnostics, Inc.20141—
+1K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc.20143—
+2K143636IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin…Siemens Healthcare Diagnostics, Inc.20150—
+2K143352IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3…Siemens Healthcare Diagnostics, Inc.20140—