510(k) Report

Devices descending from K010237

26 later devices reach Elecsys HCG+B Calcheck through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092168Elecsys HCG+B Calcheck 5Roche Diagnostics200925—
+2K140505Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and…Siemens Healthcare Diagnostics, Inc.20143—
+2K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Siemens Healthcare Diagnostics, Inc.201313—
+2K101075Elecsys Insulin Calcheck 5Roche Diagnostics Corp.201016—
+2K094031Elecsys Folate Iii Calcheck 5Roche Diagnostics20100—
+2K100594Elecsys Troponin I Calcheck 5Roche Diagnostics20101—
+2K093700Elecsys HCG Stat Calcheck 5Roche Diagnostics Corp.20100—
+3K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Siemens Healthcare Diagnostics, Inc.20162—
+3K143352IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3…Siemens Healthcare Diagnostics, Inc.20140—
+3K142878IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High…Siemens Healthcare Diagnostics, Inc.20140—
+3K142864ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI)…Siemens Healthcare Diagnostics, Inc.20141—
+3K142811IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3…Siemens Healthcare Diagnostics, Inc.20140—
+3K141772Immulte 2000 Rubella Quantitative Igg Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20140—
+3K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc.20143—
+3K140541Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration…Siemens Healthcare Diagnostics, Inc.20142—
+3K140267Advia Centaur Tni-Ultra Master Curve Material (MCM), Advia Centaur Digoxin Master Curve…Siemens Healthcare Diagnostics, Inc.20140—
+3K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification…Siemens Healthcare Diagnostics, Inc.20147—
+4K191533ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc.20190—
+4K190121Ids SHBGImmunodiagnostic Systems, Ltd.20190—
+4K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorSiemens Healthcare Diagnostics20160—
+4K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…Siemens Healthcare Diagnostics, Inc.20150—
+4K143373IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic…Siemens Healthcare Diagnostics, Inc.20150—
+4K143636IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin…Siemens Healthcare Diagnostics, Inc.20150—
+4K143639IMMULITE 2000 CEA Calibration Verification MaterialSiemens Healthcare Diagnostics20150—
+4K143504IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin…Siemens Healthcare Diagnostics, Inc.20150—
+4K141444Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration…Siemens Healthcare Diagnostics, Inc.20141—