510(k) Report

Devices descending from K033937

19 later devices reach Elecsys Precicontrol Multianalyte through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102157Elecsys Precicontrol MultimarkerRoche Diagnostics20109—
+1K051687Elecsys Precicontrol UniversalRoche Diagnostics Corp.20052—
+1K051517Elecsys Precicontrol AnemiaRoche Diagnostics Corp.20058—
+2K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics20128—
+2K090541Elecsys Precicontrol UniversalRoche Diagnostics20091—
+2K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp.20097—
+3K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics201742
+3K141426Elecsys Folate IiiRoche Diagnostics20140—
+3K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+3K130469Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control…DiaSorin, Inc.20130—
+3K111506Elecsys Precicontrol Varia 3Roche Diagnostics201131
+3K103716Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics20111—
+4K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+4K233060Elecsys Folate IIIRoche Diagnostics20240—
+4K210901Elecsys Vitamin D total IIIRoche Diagnostics20211—
+4K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—
+4K170938CalSet IGF-1Roche Diagnostics20170—
+4K170678Beta-CrossLaps CalCheck 5Roche Diagnostics20170—
+5K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,20230—