510(k) Report

Devices descending from K961491

7 later devices reach Elecsys TSH Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162606Elecsys TSH assay, cobas e 801 Immunoassay analyzerRoche Diagnostics201713
+1K130469Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control…DiaSorin, Inc.20130—
+1K062581Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay SystemOlympus America, Inc.20060—
+1K060754Elecsys TSH Calset W/Models 04738551Roche Diagnostics Corp.20061—
+1K962573Elecsys Precicontrol TSHBoehringer Mannheim Corp.19962—
+2K223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.20230—
+2K140534Elecsys Precicontrol TSRoche Diagnostics20140—