Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

479 results for "Roche Diagnostics"
1–24 of 479
Cleared Feb 12, 2026
ISE indirect K for Gen.2
K253491 · CEM
Roche Diagnostics
Chemistry · 111d
Cleared Feb 12, 2026
Glucose HK Gen.3
K253490 · CFR
Roche Diagnostics
Chemistry · 111d
Cleared Dec 17, 2025
Elecsys Anti-SARS-CoV-2
K253839 · QVP
Roche Diagnostics
Microbiology · 16d
Cleared Oct 24, 2025
CoaguChek XS Plus System
K253188 · GJS
Roche Diagnostics
Hematology · 28d
Cleared Oct 08, 2025
Elecsys Phospho-Tau (181P) Plasma
K252163 · SET
Roche Diagnostics
Immunology · 90d
Cleared Jul 17, 2025
Elecsys Cortisol III
K242505 · JFT
Roche Diagnostics
Chemistry · 329d
Cleared Jun 10, 2025
Elecsys Anti-SARS-CoV-2
K250768 · QVP
Roche Diagnostics
Microbiology · 89d
Cleared Feb 07, 2025
Elecsys sFlt-1 and Elecsys PlGF
K241453 · QWH
Roche Diagnostics
Chemistry · 261d
Cleared Jan 24, 2025
Tina-quant Lipoprotein(a) Gen.2 Molarity
K241220 · DFC
Roche Diagnostics Operations
Chemistry · 268d
Cleared Jun 17, 2024
Elecsys Folate III
K233060 · CGN
Roche Diagnostics
Chemistry · 266d
Cleared Apr 26, 2024
cobas pulse blood glucose monitoring system
K220272 · PZI
Roche Diagnostics
Chemistry · 816d
Cleared Mar 22, 2024
Elecsys PTH , Elecsys PTH STAT
K231927 · CEW
Roche Diagnostics
Chemistry · 266d
Cleared Feb 20, 2024
ONLINE TDM Methotrexate
K233454 · LAO
Roche Diagnostics Operations
Toxicology · 123d
Cleared Sep 30, 2023
Elecsys Tg II
K221890 · MSW
Roche Diagnostics
Immunology · 458d
Cleared Sep 15, 2023
Elecsys Anti-Tg
K222610 · JZO
Roche Diagnostics
Immunology · 382d
Cleared Jul 21, 2023
Elecsys proBNP II, Elecsys proBNP II STAT
K223637 · NBC
Roche Diagnostics
Chemistry · 228d
Cleared Jun 05, 2023
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
K231348 · QSE
Roche Diagnostics
Immunology · 27d
Cleared Apr 07, 2023
Elecsys FT4 IV
K220456 · CEC
Roche Diagnostics
Chemistry · 414d
Cleared Mar 30, 2023
ONLINE TDM Phenytoin - Free Phenytoin application
K230161 · MOJ
Roche Diagnostics
Chemistry · 69d
Cleared Jan 04, 2023
Elecsys Anti-HCV II (08837031190)
K221693 · MZO
Roche Diagnostics
Microbiology · 208d
Cleared Dec 23, 2022
ONLINE DAT Benzodiazepines II
K221765 · JXM
Roche Diagnostics
Toxicology · 189d
Cleared Dec 07, 2022
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
K221842 · QSE
Roche Diagnostics
Immunology · 166d
Cleared Oct 12, 2022
Elecsys HSV-2 IgG (08948887160)
K220924 · MYF
Roche Diagnostics
Microbiology · 195d
Cleared Oct 12, 2022
Elecsys HSV-1 IgG (08948844160)
K220923 · MXJ
Roche Diagnostics
Microbiology · 195d