Medical Device Manufacturer · US , Indianapolos , IN

Roche Diagnostics - FDA 510(k) Cleared Devices

182 submissions · 180 cleared · Since 2005

Recent clearances: Elecsys Anti-SARS-CoV-2 S, Elecsys Anti-HBc II, Elecsys Anti-HAV IgM

Official Website

182

Total

180

Cleared

2

Denied

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

27 devices

1-12 of 27

Cleared Apr 13, 2026

Elecsys Anti-SARS-CoV-2 S

Microbiology · 265d

Cleared Apr 07, 2026

Elecsys Anti-HBc II

Microbiology · 90d

Cleared Apr 07, 2026

Elecsys Anti-HAV IgM

Microbiology · 90d

Cleared Apr 07, 2026

Elecsys Anti-HBc IgM

Microbiology · 90d

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