510(k) Report

Devices descending from K082340

7 later devices reach Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche… through their predicates, nearest generation first.

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