510(k) Report

Devices descending from K981931

9 later devices reach Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051292Elecsys RBC Folate Hemolyzed ReagentRoche Diagnostics Corp.20058—
+2K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp.20097—
+3K141426Elecsys Folate IiiRoche Diagnostics20140—
+3K111506Elecsys Precicontrol Varia 3Roche Diagnostics201131
+3K103716Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics20111—
+4K233060Elecsys Folate IIIRoche Diagnostics20240—
+4K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+5K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+5K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—