510(k) Report

Devices descending from K961489

5 later devices reach Elecsys FT4 Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132058Vidas FT4Biomerieux S.A.20150—
+1K131244Elecsys FT4 II Assay, Elecsys FT4 II CalsetRoche Diagnostics20142—
+1K121951Liaison FT4 Liaison Control Thyroid 1 Liaison Control Thyroid 2 Liaison Control Thyroid 3DiaSorin, Inc.20130—
+2K220456Elecsys FT4 IVRoche Diagnostics20230—
+2K181233Elecsys FT4 IIIRoche Diagnostics20180—