510(k) Report

Devices descending from K152526

2 later devices reach Elecsys Progesterone III CalSet through their predicates, nearest generation first.

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