510(k) Report

Devices descending from K963167

17 later devices reach Elecys Calcheck T 3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111552Elecsys T3 Calcheck 5Roche Diagnostics201116—
+2K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…Siemens Healthcare Diagnostics, Inc.20150—
+2K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…Siemens Healthcare Diagnostics, Inc.20135—
+2K112528Elecsys T4 Calcheck 5Roche Diagnostics Corporation201115—
+3K141444Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration…Siemens Healthcare Diagnostics, Inc.20141—
+3K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc.20143—
+3K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+3K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics20128—
+4K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+4K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—
+4K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics201742
+4K143636IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin…Siemens Healthcare Diagnostics, Inc.20150—
+4K143352IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3…Siemens Healthcare Diagnostics, Inc.20140—
+5K210901Elecsys Vitamin D total IIIRoche Diagnostics20211—
+5K170938CalSet IGF-1Roche Diagnostics20170—
+5K170678Beta-CrossLaps CalCheck 5Roche Diagnostics20170—
+6K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,20230—