Medical Device Manufacturer · US , Indianapolos , IN

Roche Diagnostics - FDA 510(k) Cleared Devices

177 submissions · 175 cleared · Since 2005

Official Website

177

Total

175

Cleared

2

Denied

FDA 510(k) cleared devices by Roche Diagnostics Microbiology ✕

23 devices

1-12 of 23

Cleared Dec 17, 2025

Elecsys Anti-SARS-CoV-2

Microbiology · 16d

Cleared Jun 10, 2025

Elecsys Anti-SARS-CoV-2

Microbiology · 89d

Cleared Jan 04, 2023

Elecsys Anti-HCV II (08837031190)

Microbiology · 208d

Cleared Oct 12, 2022

Elecsys CMV IgG

Microbiology · 197d

Cleared Oct 12, 2022

Elecsys HSV-1 IgG (08948844160)

Microbiology · 195d

Cleared Oct 12, 2022

Elecsys HSV-2 IgG (08948887160)

Microbiology · 195d

Cleared Jul 20, 2021

Elecsys Syphilis

Microbiology · 82d

Cleared Mar 09, 2020

Elecsys BRAHMS PCT

Microbiology · 160d

Cleared Aug 13, 2019

Elecsys Anti-HAV II

Microbiology · 172d

Cleared Jul 06, 2018

Elecsys BRAHMS PCT

Microbiology · 192d

Cleared Jun 23, 2017

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl

Microbiology · 270d

Cleared Mar 17, 2017

Elecsys CMV IgM

Microbiology · 88d