510(k) Report

Devices descending from K003409

2 later devices reach Elecsys FSH Calset II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012399Modification to Elecsys FSH II CalsetRoche Diagnostics Corp.20011—
+2K163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.20170—