Roche Diagnostics - FDA 510(k) Cleared Devices
177
Total
175
Cleared
2
Denied
FDA 510(k) cleared devices by Roche Diagnostics Immunology ✕
24 devices
Cleared
Oct 08, 2025
Elecsys Phospho-Tau (181P) Plasma
Immunology
90d
Cleared
Sep 30, 2023
Elecsys Tg II
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
Elecsys AFP
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
Cleared
Jun 15, 2016
ROMA Calculation Tool Using Elecsys Assays
Immunology
181d
Cleared
Jun 06, 2014
CA 125 II CALSET II
Immunology
142d
Cleared
Dec 05, 2012
ELECSYS CA 15-3 II CALCHECK 5
Immunology
131d
Cleared
Sep 10, 2012
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4...
Immunology
368d
Cleared
Feb 11, 2011
ELECSYS ANTI-TPO CALSET
Immunology
107d
Cleared
Nov 01, 2010
ELECSYS CA 125 II CALCHECK 5
Immunology
98d
Cleared
Oct 07, 2010
ELECSYS IGE CALCHECK 5
Immunology
59d
Cleared
Oct 05, 2010
ELECSYS CEA CALCHECK 5
Immunology
96d
Cleared
Jun 22, 2010
TINA-QUANT FERRITIN GEN. 4
Immunology
117d
Cleared
Mar 18, 2010
TINA-QUANT CERULOPLASMIN
Immunology
275d
Cleared
Sep 11, 2008
ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP
Immunology
121d
Cleared
Aug 31, 2006
ELECSYS IGE II IMMUNOASSAY
Immunology
50d
Cleared
Mar 13, 2006
COBAS 6000 SERIES SYSTEM
Immunology
28d