510(k) Report

Devices descending from K973674

10 later devices reach Elecsys Folate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031756Roche Diagnostics Elecsys Folate II AssayRoche Diagnostics Corp.20039—
+2K043318Modification to Roche Elecsys Folate II ImmunoassayRoche Diagnostics Corp.200481
+3K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp.20097—
+4K141426Elecsys Folate IiiRoche Diagnostics20140—
+4K111506Elecsys Precicontrol Varia 3Roche Diagnostics201131
+4K103716Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics20111—
+5K233060Elecsys Folate IIIRoche Diagnostics20240—
+5K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+6K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+6K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—