510(k) Report

Devices descending from K032134

3 later devices reach TSH Receptor Antibody (Trab) Coated Tube (CT) Assay Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083391Thyroid Stimulating Immunoglobulin Reporter AssayDiagnostic Hybrids, Inc.20092—
+2K092229Thyretain TM Tsi Reporter BioassayDiagnostic Hybrids, Inc.20101—
+3K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.201601