510(k) Report

Devices descending from K924862

55 later devices reach Aia-Pack HCG Calibration Verification Test Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K963181Elecsys Calcheck T UpdateBoehringer Mannheim Corp.19960—
+1K963165Elecsys Calcheck HCGBoehringer Mannheim Corp.19960—
+1K963178Elecsys Calcheck T4Boehringer Mannheim Corp.19960—
+1K963163Elecsys Calcheck FT3Boehringer Mannheim Corp.19960—
+1K963167Elecys Calcheck T 3Boehringer Mannheim Corp.199617—
+1K963164Elecsys Calcheck FT4Boehringer Mannheim Corp.19960—
+1K963143Elecsys Calcheck Troponin TBoehringer Mannheim Corp.19960—
+1K963182Elecsys Calcheck CK-MBBoehringer Mannheim Corp.19960—
+1K963147Elecsys Calcheck TSHBoehringer Mannheim Corp.199632—
+2K111552Elecsys T3 Calcheck 5Roche Diagnostics201116—
+2K093836Elecsys TSH Calcheck 5Roche Diagnostics20100—
+2K020369Elecsys Anti-TG CalcheckRoche Diagnostics Corp.20021—
+2K974384Elecsys Calcheck FolateBoehringer Mannheim Corp.19979—
+2K974383Elecsys Calcheck Vitamin B12Boehringer Mannheim Corp.199710—
+2K973973Elecsys Callcheck DigoxinBoehringer Mannheim Corp.19973—
+2K970458Elecsys Calcheck PsaBoehringer Mannheim Corp.19970—
+2K970452Elecsys Calcheck CeaBoehringer Mannheim Corp.19971—
+2K970459Elecsys Calcheck CeaBoehringer Mannheim Corp.19970—
+3K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…Siemens Healthcare Diagnostics, Inc.20150—
+3K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…Siemens Healthcare Diagnostics, Inc.20135—
+3K132391Immulite 2000 Anti-TG AB Calibration Verification Material, Immulite 2000 Anti-Tpo AB…Siemens Helathcare Diagnostics, Inc.20130—
+3K112528Elecsys T4 Calcheck 5Roche Diagnostics Corporation201115—
+3K101856Elecsys Cea Calcheck 5Roche Diagnostics20100—
+3K102044Elecsys Digoxin Calcheck 5Roche Diagnostics20102—
+3K060755Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp.20069—
+3K043320Modification to Roche Elecsys Folate II Calcheck IIRoche Diagnostics Corp.20048—
+4K151786Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSetRoche Diagnostics20150—
+4K141444Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration…Siemens Healthcare Diagnostics, Inc.20141—
+4K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc.20143—
+4K140505Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and…Siemens Healthcare Diagnostics, Inc.20143—
+4K140267Advia Centaur Tni-Ultra Master Curve Material (MCM), Advia Centaur Digoxin Master Curve…Siemens Healthcare Diagnostics, Inc.20140—
+4K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+4K121994Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4…Siemens Healthcare Diagnostics, Inc.20121—
+4K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics20128—
+4K110579Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 ControlsAbbott Laboratories20111—
+4K112113Elecsys Myoglobin Calcheck 5Roche Diagnostics20110—
+4K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp.20097—
+5K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+5K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—
+5K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics201742
+5K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Siemens Healthcare Diagnostics, Inc.20162—
+5K143636IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin…Siemens Healthcare Diagnostics, Inc.20150—
+5K143352IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3…Siemens Healthcare Diagnostics, Inc.20140—
+5K141426Elecsys Folate IiiRoche Diagnostics20140—
+5K133512Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal)Siemens Healthcare Diagnostics20140—
+5K121314Architect B12Abbott Laboratories20120—
+5K111506Elecsys Precicontrol Varia 3Roche Diagnostics201131
+5K103716Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics20111—
+6K233060Elecsys Folate IIIRoche Diagnostics20240—
+6K210901Elecsys Vitamin D total IIIRoche Diagnostics20211—
+6K191533ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc.20190—
+6K190121Ids SHBGImmunodiagnostic Systems, Ltd.20190—
+6K170938CalSet IGF-1Roche Diagnostics20170—
+6K170678Beta-CrossLaps CalCheck 5Roche Diagnostics20170—
+7K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,20230—