510(k) Report

Devices descending from K935286

26 later devices reach Quantaphase II B12/Folate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984166Vitros Immunodiagnostic Products Folate Reagent Pack 1/2, Vitros Immunodiagnostic…Ortho-Clinical Diagnostics, Inc.199901
+1K984321Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3…Ortho-Clinical Diagnostics, Inc.199901
+1K981931Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys Folate AssayRoche Diagnostics/Boehringer Mannheim GmbH19989—
+1K973702Elecsys Vitamin B12 AssayBoehringer Mannheim Corp.199710—
+1K973674Elecsys FolateBoehringer Mannheim Corp.199710—
+2K060755Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp.20069—
+2K051292Elecsys RBC Folate Hemolyzed ReagentRoche Diagnostics Corp.20058—
+2K031756Roche Diagnostics Elecsys Folate II AssayRoche Diagnostics Corp.20039—
+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—
+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—
+3K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp.20097—
+3K043318Modification to Roche Elecsys Folate II ImmunoassayRoche Diagnostics Corp.200481
+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—