510(k) Report

Devices descending from K992981

3 later devices reach Elecsys Estradiol Calset II through their predicates, nearest generation first.

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