Roche Diagnostics - FDA 510(k) Cleared Devices
177
Total
175
Cleared
2
Denied
FDA 510(k) cleared devices by Roche Diagnostics Microbiology ✕
23 devices
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
Cleared
Jul 28, 2016
Elecsys Syphilis
Microbiology
118d
Cleared
Jun 13, 2016
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
Microbiology
89d
Cleared
Oct 24, 2014
ELECYS CMV IGM IMMUNOASSAY
Microbiology
81d
Cleared
Feb 28, 2014
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
Microbiology
270d
Cleared
Aug 24, 2012
ELECSYS HSV-2 IGG IMMUNOASSAY
Microbiology
56d
Cleared
Jul 25, 2012
ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
Microbiology
146d
Cleared
Jun 22, 2010
ANTI-HAV IGM
Microbiology
181d
Cleared
Mar 12, 2010
ELECSYS RUBELLA IGM IMMUNOASSAY
Microbiology
220d
Cleared
Oct 30, 2009
ELECSYS RUBELLA IGGA CALCHECK 5
Microbiology
67d
Cleared
May 05, 2009
ELECSYS RUBELLA IGG CALCHECK
Microbiology
88d
Cleared
Feb 12, 2009
ELECSYS TOXO IGG CALCHECK
Microbiology
64d