510(k) Report

Devices descending from K980812

16 later devices reach Imx Homocysteine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984071Liquichek Homocysteine Control, Cat #644Bio-Rad199815—
+2K100715Audit Microcv Homocysteine Linearity Set, Model 704M-5Aalto Scientific, Ltd.201014—
+3K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Siemens Healthcare Diagnostics, Inc.201313—
+4K143352IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3…Siemens Healthcare Diagnostics, Inc.20140—
+4K142878IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High…Siemens Healthcare Diagnostics, Inc.20140—
+4K142811IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3…Siemens Healthcare Diagnostics, Inc.20140—
+4K141772Immulte 2000 Rubella Quantitative Igg Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20140—
+4K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc.20143—
+4K140541Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration…Siemens Healthcare Diagnostics, Inc.20142—
+4K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification…Siemens Healthcare Diagnostics, Inc.20147—
+5K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…Siemens Healthcare Diagnostics, Inc.20150—
+5K143373IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic…Siemens Healthcare Diagnostics, Inc.20150—
+5K143636IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin…Siemens Healthcare Diagnostics, Inc.20150—
+5K143639IMMULITE 2000 CEA Calibration Verification MaterialSiemens Healthcare Diagnostics20150—
+5K143504IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin…Siemens Healthcare Diagnostics, Inc.20150—
+5K141444Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration…Siemens Healthcare Diagnostics, Inc.20141—