510(k) Report

Devices descending from K083391

2 later devices reach Thyroid Stimulating Immunoglobulin Reporter Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092229Thyretain TM Tsi Reporter BioassayDiagnostic Hybrids, Inc.20101—
+2K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.201601