510(k) Report

Devices descending from K962573

2 later devices reach Elecsys Precicontrol TSH through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140534Elecsys Precicontrol TSRoche Diagnostics20140—
+1K062581Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay SystemOlympus America, Inc.20060—