Roche Diagnostics - FDA 510(k) Cleared Devices

Cleared Oct 08, 2025

Elecsys Phospho-Tau (181P) Plasma

K252163 · SET

Immunology · 90d

Cleared Sep 30, 2023

Elecsys Tg II

K221890 · MSW

Immunology · 458d

Cleared Sep 15, 2023

Elecsys Anti-Tg

K222610 · JZO

Immunology · 382d

Cleared Jun 05, 2023

Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF

K231348 · QSE

Immunology · 27d

Cleared Dec 07, 2022

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF

K221842 · QSE

Immunology · 166d

Cleared Sep 15, 2022

Elecsys AFP

K220176 · LOJ

Immunology · 237d

Cleared Feb 27, 2020

Elecsys Anti-TSHR

K193313 · JZO

Immunology · 90d

Cleared Jun 22, 2018

Elecsys CA 15-3 II

K181492 · MOI

Immunology · 16d

Cleared Feb 20, 2018

Elecsys CA 15-3 II

K171605 · MOI

Immunology · 264d

Cleared Jan 12, 2017

Elecsys CYFRA 21-1 CalCheck 5

K162173 · JJX

Immunology · 162d

Cleared Dec 14, 2016

Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker

K160915 · OVK

Immunology · 257d

Cleared Jun 15, 2016

ROMA Calculation Tool Using Elecsys Assays

K153607 · ONX

Immunology · 181d