510(k) Report

Devices descending from DEN070009

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130010Prosigna (TM) Breast Cancer Prognostic Gene Signature AssayNanostring Technologies20131—
+1K101185Nucleic Acid Detection Immunoassay (Nadia) Psa AssayIris Molecular Diagnostics20110—
+1K100015Vysis CLL Fish Probe Kit (Vysis Lsi TP53 Spectrumorange/Atm Spectrumgreen) and Lsi…Abbott Molecular, Inc.20111—
+1K070675MammaprintAgendia BV200781
+2K141771Prosigna Breast Cancer Prognostic Gene Signature AssayNanostring Technologies, Inc.20140—
+2K091960Vysis EGR1 Fish Probe Kit (Vysis Lsi EGR1 Spectrum/Orange/D5S23, D5S721, Spectrum Green…Abbott Molecular, Inc.20110—
+2K080252Modification to MammaprintAgendia BV200871
+3K081092Modification to MammaprintAgendia200961
+4K101454MammaprintAgendia20113—
+5K141142Mammaprint FfpeAgendia20152—
+6K201902MammaPrintAgendia, Inc.20201—
+7K210973MammaPrint FFPE NGS KitAgendia, Inc.20220—