510(k) Report

Devices descending from K080643

1 later device reach Elecsys Anti-TSHR Calcheck through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.201601