510(k) Report

Devices descending from K964841

3 later devices reach Elecsys Progesterone Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152526Elecsys Progesterone III CalSetRoche Diagnostics20152—
+2K163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.20170—
+2K160729Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5Roche Diagnostics201601