510(k) Report

Devices descending from K080092

3 later devices reach Elecsys Anti-TSHR Immunoassay, Elecsys Precicontrol Thyroab through their predicates, nearest generation first.

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