Roche Diagnostics - FDA 510(k) Cleared Devices
Recent clearances: Elecsys Anti-SARS-CoV-2 S, Elecsys Anti-HBc II, Elecsys Anti-HAV IgM
182
Total
180
Cleared
2
Denied
FDA 510(k) Regulatory Record - Roche Diagnostics Chemistry ✕
116 devices
Cleared
Apr 02, 2026
Tina-quant Cardiac high sensitivity CRP III
Chemistry
87d
Cleared
Feb 12, 2026
Glucose HK Gen.3
Chemistry
111d
Cleared
Feb 12, 2026
ISE indirect K for Gen.2
Chemistry
111d
Cleared
Jul 17, 2025
Elecsys Cortisol III
Chemistry
329d
Cleared
Feb 07, 2025
Elecsys sFlt-1 and Elecsys PlGF
Chemistry
261d
Cleared
Jun 17, 2024
Elecsys Folate III
Chemistry
266d
Cleared
Apr 26, 2024
cobas pulse blood glucose monitoring system
Chemistry
816d
Cleared
Mar 22, 2024
Elecsys PTH , Elecsys PTH STAT
Chemistry
266d
Cleared
Jul 21, 2023
Elecsys proBNP II, Elecsys proBNP II STAT
Chemistry
228d
Cleared
Apr 07, 2023
Elecsys FT4 IV
Chemistry
414d
Cleared
Mar 30, 2023
ONLINE TDM Phenytoin - Free Phenytoin application
Chemistry
69d
Cleared
Sep 16, 2022
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2,...
Chemistry
241d
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