510(k) Report

Devices descending from K101454

3 later devices reach Mammaprint through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141142Mammaprint FfpeAgendia20152—
+2K201902MammaPrintAgendia, Inc.20201—
+3K210973MammaPrint FFPE NGS KitAgendia, Inc.20220—