510(k) Report

Devices descending from K140541

2 later devices reach Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143373IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic…Siemens Healthcare Diagnostics, Inc.20150—
+1K143504IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin…Siemens Healthcare Diagnostics, Inc.20150—