510(k) Report

Devices descending from K033454

4 later devices reach Brahms Diagnostica Lumitest Trak Human through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080092Elecsys Anti-TSHR Immunoassay, Elecsys Precicontrol ThyroabRoche Diagnostics Corp.20083—
+2K193313Elecsys Anti-TSHRRoche Diagnostics202001
+2K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.201601
+2K092320Elecsys Precicontrol ThyroabRoche Diagnostics20090—