510(k) Report

Devices descending from K051292

8 later devices reach Elecsys RBC Folate Hemolyzed Reagent through their predicates, nearest generation first.

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