510(k) Report

Devices descending from K950469

48 later devices reach Document Serum Multianalyte Calibration Verification Test Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023352Validate Chem 9 Calibration Verification Test Set, Model 109Maine Standards Co.20020—
+1K992034Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine)199929—
+1K990608Architect Cea Mastercheck, Model 6CO2-05Bio-Rad19990—
+1K990393Architect Progesterone Mastercheck Model #6C26-05Bio-Rad19991—
+1K984625Architect Folate Masterchek, Model # 6C12-05Bio-Rad19990—
+1K984604Architect Estradiol Masterchek, Model # 6C22-05Bio-Rad19990—
+1K984626Architect B12 Masterchek, Model # 6C09-O5Bio-Rad19990—
+1K984319Architect Free T3 Mastercheck, Model Number 6C48-05Bio-Rad19980—
+1K984327Architect Total T3 Mastercheck, Model Number 6C51-05Bio-Rad19980—
+1K984325Architect Ferritin Mastercheck, Model Number 6C11-05Bio-Rad19980—
+1K984323Architect LH Mastercheck, Model Number 6C25-05Bio-Rad199801
+1K984318Architect FSH Mastercheck, Model Number 6C24-05Bio-Rad19980—
+1K984324Architect Prolactin Mastercheck, Model Number 6C27-05Bio-Rad199801
+1K984073Architect Total P-HCG Mastercheck, List NO. 6C21-05Bio-Rad19980—
+1K984070Architect Free T4 Mastercheck, List NO. 6C50-05Bio-Rad199801
+1K984072Architect TSH Mastercheck, List NO, 6C52-05Bio-Rad19980—
+1K984074Architect Total T4 Mastercheck, List NO. 6C49-05Bio-Rad199801
+1K983578Architect Testosterone Mastercheck, Model 6C28-05Bio-Rad19980—
+2K062501Validate Thyroid Calibration Verification / Linearity Test Set, Model 901Maine Standards Co.200626—
+2K042335Architect Free Psa Mastercheck, Model 6C07-05; Architect Tital Psa Mastercheck, Model…Bio-Rad Laboratories, Inc.20040—
+2K041073Document Salicylate Cal VerMicrogenics Corp.20040—
+2K993014Modification to Document Thyroid Cal.VerCasco-Nerl Diagnostics Corporation (Maine)19990—
+3K110586Advia Centaur Vitamin D Total AssaySiemens Healthcare Diagnostics, Inc.201137
+3K102904Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics201018—
+3K092993Advia Centaur Cyclosporine Master Curve MaterialSiemens Healthcare Diagnostics20090—
+3K091123Advia Centaur Dheas Master Curve MaterialsSiemens Healthcare Diagnostics20090—
+3K083891Validate Thyroid Calibration Verification Test Set, Model 901Maine Standards Co.20090—
+4K162298LOCI Total Vitamin D Total Assay, LOCI VITD CALSiemens Healthcare Diagnostics20170—
+4K133156Advia Centaur Vitamin D Total (Vitd) Assay;Advia Centaur Vitd Total Calibrators,Quality…Siemens Healthcare Diagnostics, Inc.20141—
+4K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…Siemens Healthcare Diagnostics, Inc.20135—
+4K110061CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics201114—
+4K103683Immulite/Immulite 1000 Progesterone Calibration Verification (CVM)Siemens Healthcare Diagnostics20111—
+5K200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc.20200—
+5K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…Siemens Healthcare Diagnostics, Inc.20150—
+5K143376ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master…Siemens Healthcare Diagnostics, Inc.20140—
+5K141444Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration…Siemens Healthcare Diagnostics, Inc.20141—
+5K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc.20143—
+5K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Siemens Healthcare Diagnostics, Inc.201313—
+6K143636IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin…Siemens Healthcare Diagnostics, Inc.20150—
+6K143352IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3…Siemens Healthcare Diagnostics, Inc.20140—
+6K142878IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High…Siemens Healthcare Diagnostics, Inc.20140—
+6K142811IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3…Siemens Healthcare Diagnostics, Inc.20140—
+6K141772Immulte 2000 Rubella Quantitative Igg Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.20140—
+6K140541Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration…Siemens Healthcare Diagnostics, Inc.20142—
+6K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification…Siemens Healthcare Diagnostics, Inc.20147—
+7K143373IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic…Siemens Healthcare Diagnostics, Inc.20150—
+7K143639IMMULITE 2000 CEA Calibration Verification MaterialSiemens Healthcare Diagnostics20150—
+7K143504IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin…Siemens Healthcare Diagnostics, Inc.20150—