510(k) Report

Devices descending from K140258

7 later devices reach Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143373IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic…Siemens Healthcare Diagnostics, Inc.20150—
+1K143639IMMULITE 2000 CEA Calibration Verification MaterialSiemens Healthcare Diagnostics20150—
+1K143504IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin…Siemens Healthcare Diagnostics, Inc.20150—
+1K142878IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High…Siemens Healthcare Diagnostics, Inc.20140—
+1K142811IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3…Siemens Healthcare Diagnostics, Inc.20140—
+1K141444Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration…Siemens Healthcare Diagnostics, Inc.20141—
+2K143636IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin…Siemens Healthcare Diagnostics, Inc.20150—