510(k) Report

Devices descending from K910440

41 later devices reach Document Reflectance II Linearity Test Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023410Validate Chem 10 Calibration Verification Test Set, Model 110Maine Standards Co.200340—
+2K042318Audit Microcv General Chemistry Linearity SetAalto Scientific, Ltd.200439—
+3K111964Audit Microcv Urine/Fluids Chemistry LinearityAalto Scientific, Ltd.20120—
+3K101216Audit Microcv Protein Linearity SetAalto Scientific, Ltd.20112—
+3K102617Audit Microcv Cardiac Markers Linearity SetAalto Scientific, Ltd.20110—
+3K101427Audit Microcv HS-CRP Linearity SetAalto Scientific, Ltd.20105—
+3K100715Audit Microcv Homocysteine Linearity Set, Model 704M-5Aalto Scientific, Ltd.201014—
+3K101226Audit Microcv RF/CRP Linearity SetAalto Scientific, Ltd.20100—
+3K101434Audit Microcv Procalcitonin LinearityAalto Scientific, Ltd.20100—
+3K100750Audit Microcv Aso Linearity Set, Model K721M-5Aalto Scientific, Ltd.20100—
+3K082714Audit Microcv Therapeutic Drug (TDM) Linearity Set, Model K707M-5Aalto Scientific, Ltd.20083—
+3K082717Audit Microcv Tumor Markers Linearity Set, Model K719M-5Aalto Scientific, Ltd.20081—
+3K070223Audit Microcv Lipids Linearity Set (Low)Aalto Scientific, Ltd.20070—
+3K062668Audit Microcv Immunoassay Linearity SetAalto Scientific, Ltd.20062—
+4K143573Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.20150—
+4K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Siemens Healthcare Diagnostics, Inc.201313—
+4K130762Audit Microcv Therapeutic Drug (TDM) Linearity SetAalto Scientific, Ltd.20132—
+4K130764Audit Microcv Vitamin D Linearity SetAalto Scientific, Ltd.20130—
+4K130157Audit Microcv Beta-Hydroxybutyric Acid Linearity SetAalto Scientific, Ltd.20133—
+4K112742Audit Microlq Spinal Fluid ControlAalto Scientific, Ltd.20120—
+4K112143Audit Microcv T-Uptake LinearityAalto Scientific, Ltd.20120—
+4K112705Audit (R) Microlq (TM) Serum Protein ControlAalto Scientific, Ltd.20120—
+4K103601Audit Microcv Immunoassay Linearity SetAalto Scientific, Ltd.20110—
+5K163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.20170—
+5K161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.20160—
+5K143571Audit MicroControls Linearity LQ Cystatin-CAalto Scientific, Ltd.20150—
+5K143352IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3…Siemens Healthcare Diagnostics, Inc.20140—
+5K143026Audit MicroControls Linearity FD Unsaturated Iron Binding CapacityAalto Scientific, Ltd.20140—
+5K142978Audit MicroControls Linearity LQ Special DiabetesAalto Scientific, Ltd.20140—
+5K142878IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High…Siemens Healthcare Diagnostics, Inc.20140—
+5K142811IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3…Siemens Healthcare Diagnostics, Inc.20140—
+5K141772Immulte 2000 Rubella Quantitative Igg Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20140—
+5K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc.20143—
+5K140541Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration…Siemens Healthcare Diagnostics, Inc.20142—
+5K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification…Siemens Healthcare Diagnostics, Inc.20147—
+6K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…Siemens Healthcare Diagnostics, Inc.20150—
+6K143373IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic…Siemens Healthcare Diagnostics, Inc.20150—
+6K143636IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin…Siemens Healthcare Diagnostics, Inc.20150—
+6K143639IMMULITE 2000 CEA Calibration Verification MaterialSiemens Healthcare Diagnostics20150—
+6K143504IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin…Siemens Healthcare Diagnostics, Inc.20150—
+6K141444Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration…Siemens Healthcare Diagnostics, Inc.20141—