510(k) Report

Devices descending from K965109

4 later devices reach Elecsys Estradiol Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992981Elecsys Estradiol Calset IIRoche Diagnostics Corp.19993—
+2K142021Elecsys Estradiol III CalSetRoche Diagnostics20141—
+2K101460Loci 8 Calibrator, Model KC 646Siemens Healthcare Diagnostics201001
+3K163053Lumipulse G E2-III CalibratorsFujirebio Diagnostics,Inc.20160—