Medical Device Manufacturer · US , Indianapolos , IN

Roche Diagnostics - FDA 510(k) Cleared Devices

184 submissions · 182 cleared · Since 2005

Recent clearances: Elecsys Phospho-Tau (217P) Plasma, cobas pulse blood glucose monitoring system, Elecsys Anti-SARS-CoV-2 S

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184

Total

182

Cleared

2

Denied

FDA 510(k) Regulatory Record - Roche Diagnostics Immunology ✕

25 devices

1-12 of 25

Cleared Aug 19, 2026

Elecsys Phospho-Tau (217P) Plasma

Immunology · 90d

Cleared Oct 08, 2025

Elecsys Phospho-Tau (181P) Plasma

Immunology · 90d

Cleared Sep 30, 2023

Immunology · 458d

Cleared Sep 15, 2023

Elecsys Anti-Tg

Immunology · 382d

Cleared Jun 05, 2023

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

Immunology · 27d

Cleared Dec 07, 2022

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

Immunology · 166d

Cleared Sep 15, 2022

Immunology · 237d

Cleared Feb 27, 2020

Elecsys Anti-TSHR

Immunology · 90d

Cleared Jun 22, 2018

Elecsys CA 15-3 II

Immunology · 16d

Cleared Feb 20, 2018

Elecsys CA 15-3 II

Immunology · 264d

Cleared Jan 12, 2017

Elecsys CYFRA 21-1 CalCheck 5

Immunology · 162d

Cleared Dec 14, 2016

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

Immunology · 257d