Medical Device Manufacturer · US , Indianapolos , IN

Roche Diagnostics - FDA 510(k) Cleared Devices

188 submissions · 185 cleared · Since 2005

Recent clearances: Elecsys EBV EBNA IgG, Elecsys EBV VCA IgG, Elecsys EBV IgM

View 188 510(k) Devices ↓ Official Website

188

Total

185

Cleared

3

Denied

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

31 devices

1-12 of 31

Not Cleared Oct 20, 2026

Elecsys HBsAg II quant II RxDx

DEN260027 · SJM

Microbiology · 140d

Cleared Oct 02, 2026

Elecsys EBV EBNA IgG

Microbiology · 249d

Cleared Oct 02, 2026

Elecsys EBV VCA IgG

Microbiology · 249d

Cleared Oct 02, 2026

Elecsys EBV IgM

Microbiology · 249d

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