510(k) Report

Devices descending from K963147

32 later devices reach Elecsys Calcheck TSH through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093836Elecsys TSH Calcheck 5Roche Diagnostics20100—
+1K020369Elecsys Anti-TG CalcheckRoche Diagnostics Corp.20021—
+1K974384Elecsys Calcheck FolateBoehringer Mannheim Corp.19979—
+1K974383Elecsys Calcheck Vitamin B12Boehringer Mannheim Corp.199710—
+1K973973Elecsys Callcheck DigoxinBoehringer Mannheim Corp.19973—
+1K970458Elecsys Calcheck PsaBoehringer Mannheim Corp.19970—
+1K970452Elecsys Calcheck CeaBoehringer Mannheim Corp.19971—
+1K970459Elecsys Calcheck CeaBoehringer Mannheim Corp.19970—
+2K132391Immulite 2000 Anti-TG AB Calibration Verification Material, Immulite 2000 Anti-Tpo AB…Siemens Helathcare Diagnostics, Inc.20130—
+2K101856Elecsys Cea Calcheck 5Roche Diagnostics20100—
+2K102044Elecsys Digoxin Calcheck 5Roche Diagnostics20102—
+2K060755Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp.20069—
+2K043320Modification to Roche Elecsys Folate II Calcheck IIRoche Diagnostics Corp.20048—
+3K151786Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSetRoche Diagnostics20150—
+3K140505Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and…Siemens Healthcare Diagnostics, Inc.20143—
+3K140267Advia Centaur Tni-Ultra Master Curve Material (MCM), Advia Centaur Digoxin Master Curve…Siemens Healthcare Diagnostics, Inc.20140—
+3K121994Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4…Siemens Healthcare Diagnostics, Inc.20121—
+3K110579Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 ControlsAbbott Laboratories20111—
+3K112113Elecsys Myoglobin Calcheck 5Roche Diagnostics20110—
+3K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp.20097—
+4K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve…Siemens Healthcare Diagnostics, Inc.20162—
+4K141426Elecsys Folate IiiRoche Diagnostics20140—
+4K133512Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal)Siemens Healthcare Diagnostics20140—
+4K121314Architect B12Abbott Laboratories20120—
+4K111506Elecsys Precicontrol Varia 3Roche Diagnostics201131
+4K103716Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics20111—
+5K233060Elecsys Folate IIIRoche Diagnostics20240—
+5K191533ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGSiemens Healthcare Diagnostics, Inc.20190—
+5K190121Ids SHBGImmunodiagnostic Systems, Ltd.20190—
+5K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+6K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+6K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—