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Roche Diagnostics

FDA 510(k) & PMA Approved Devices — 70 products

Total Devices70
Categories46
Latest FDA decision2026-06-12
TypeNumberDevice NameCodeDateActions
510(k) K252323 cobas pulse blood glucose monitoring systemPZI2026-06-12 View
510(k) K252280 Elecsys Anti-SARS-CoV-2 SQVP2026-04-13 View
510(k) K260049 Elecsys Anti-HBc IgMSEI2026-04-07 View
510(k) K260046 Elecsys Anti-HBc IISEI2026-04-07 View
510(k) K260048 Elecsys Anti-HAV IgMLOL2026-04-07 View
510(k) K260026 Tina-quant Cardiac high sensitivity CRP IIINQD2026-04-02 View
510(k) K253491 ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutionsCEM2026-02-12 View
510(k) K253490 Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR2026-02-12 View
510(k) K253839 Elecsys Anti-SARS-CoV-2QVP2025-12-17 View
510(k) K253188 CoaguChek XS Plus SystemGJS2025-10-24 View
510(k) K252163 Elecsys Phospho-Tau (181P) PlasmaSET2025-10-08 View
510(k) K242505 Elecsys Cortisol IIIJFT2025-07-17 View
510(k) K250768 Elecsys Anti-SARS-CoV-2QVP2025-06-10 View
PMA P190034 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-05-22 View
PMA P190005 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-05-22 View
510(k) K241453 Elecsys sFlt-1 and Elecsys PlGFQWH2025-02-07 View
510(k) K233060 Elecsys Folate IIICGN2024-06-17 View
510(k) K220272 cobas pulse blood glucose monitoring systemPZI2024-04-26 View
510(k) K231927 Elecsys PTH , Elecsys PTH STATCEW2024-03-22 View
510(k) K221890 Elecsys Tg IIMSW2023-09-30 View

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