510(k) Report

Devices descending from K900883

6 later devices reach Enzymun Test (R) FT4 (Free Thyroxine) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961489Elecsys FT4 AssayBoehringer Mannheim Corp.19965—
+2K132058Vidas FT4Biomerieux S.A.20150—
+2K131244Elecsys FT4 II Assay, Elecsys FT4 II CalsetRoche Diagnostics20142—
+2K121951Liaison FT4 Liaison Control Thyroid 1 Liaison Control Thyroid 2 Liaison Control Thyroid 3DiaSorin, Inc.20130—
+3K220456Elecsys FT4 IVRoche Diagnostics20230—
+3K181233Elecsys FT4 IIIRoche Diagnostics20180—