Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Roche Diagnostics

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

Total Devices70
Categories46
Latest Approval2026-04-13
TypeNumberDevice NameCodeDate
510(k) K252280 Elecsys Anti-SARS-CoV-2 S QVP 2026-04-13 View
510(k) K260049 Elecsys Anti-HBc IgM SEI 2026-04-07 View
510(k) K260046 Elecsys Anti-HBc II SEI 2026-04-07 View
510(k) K260048 Elecsys Anti-HAV IgM LOL 2026-04-07 View
510(k) K260026 Tina-quant Cardiac high sensitivity CRP III NQD 2026-04-02 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 solutions CEM 2026-02-12 View
510(k) K253490 Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions CFR 2026-02-12 View
510(k) K253839 Elecsys Anti-SARS-CoV-2 QVP 2025-12-17 View
510(k) K253188 CoaguChek XS Plus System GJS 2025-10-24 View
510(k) K252163 Elecsys Phospho-Tau (181P) Plasma SET 2025-10-08 View
510(k) K242505 Elecsys Cortisol III JFT 2025-07-17 View
510(k) K250768 Elecsys Anti-SARS-CoV-2 QVP 2025-06-10 View
510(k) K241453 Elecsys sFlt-1 and Elecsys PlGF QWH 2025-02-07 View
510(k) K233060 Elecsys Folate III CGN 2024-06-17 View
510(k) K220272 cobas pulse blood glucose monitoring system PZI 2024-04-26 View
510(k) K231927 Elecsys PTH , Elecsys PTH STAT CEW 2024-03-22 View
510(k) K221890 Elecsys Tg II MSW 2023-09-30 View
510(k) K222610 Elecsys Anti-Tg JZO 2023-09-15 View
510(k) K223637 Elecsys proBNP II, Elecsys proBNP II STAT NBC 2023-07-21 View
510(k) K231348 Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF QSE 2023-06-05 View
510(k) K220456 Elecsys FT4 IV CEC 2023-04-07 View
510(k) K230161 ONLINE TDM Phenytoin - Free Phenytoin application MOJ 2023-03-30 View
510(k) K221693 Elecsys Anti-HCV II (08837031190) MZO 2023-01-04 View
510(k) K221765 ONLINE DAT Benzodiazepines II JXM 2022-12-23 View
510(k) K221842 Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF QSE 2022-12-07 View
510(k) K220923 Elecsys HSV-1 IgG (08948844160) MXJ 2022-10-12 View
510(k) K220924 Elecsys HSV-2 IgG (08948887160) MYF 2022-10-12 View
510(k) K220911 Elecsys CMV IgG LFZ 2022-10-12 View
510(k) K220134 cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH CFR 2022-09-16 View
510(k) K220176 Elecsys AFP LOJ 2022-09-15 View
510(k) K203757 Elecsys AMH PQO 2022-06-10 View
510(k) K211685 Elecsys Testosterone II CDZ 2022-05-06 View
510(k) K210546 Elecsys proBNP II, Elecsys proBNP II STAT NBC 2022-03-31 View
PMA P190034 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) LOM 2021-12-16 View
PMA P190005 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) LOM 2021-11-01 View
510(k) K201441 Elecsys Troponin T Gen 5 MMI 2021-09-21 View
510(k) K210901 Elecsys Vitamin D total III MRG 2021-09-01 View
510(k) K203227 Elecsys HCG STAT DHA 2021-08-18 View
510(k) K211302 Elecsys Syphilis LIP 2021-07-20 View
510(k) K200811 cobas u 701 microscopy analyzer LKM 2020-11-06 View
510(k) K192815 Elecsys BRAHMS PCT PRI 2020-03-09 View
510(k) K193313 Elecsys Anti-TSHR JZO 2020-02-27 View
510(k) K191899 Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions CFR 2019-08-16 View
510(k) K190428 Elecsys Anti-HAV II LOL 2019-08-13 View
510(k) K183432 cobas u 601 urinalysis test system JIL 2019-05-07 View
510(k) K190773 Elecsys TSH JLW 2019-04-16 View
510(k) K173857 Elecsys Tacrolimus MLM 2018-11-06 View
510(k) K181233 Elecsys FT4 III CEC 2018-09-18 View
510(k) K173927 Elecsys BRAHMS PCT PRI 2018-07-06 View
510(k) K181492 Elecsys CA 15-3 II MOI 2018-06-22 View
510(k) K180684 CoaguChek XS Plus System GJS 2018-04-19 View
510(k) K180693 CoaguChek XS Pro System GJS 2018-04-19 View
510(k) K171605 Elecsys CA 15-3 II MOI 2018-02-20 View
510(k) K170960 CoaguChek Vantus System GJS 2017-12-25 View
510(k) K162678 Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl LGD 2017-06-23 View
510(k) K162526 Creatine Kinase-MB JHW 2017-05-26 View
510(k) K170938 CalSet IGF-1 JIT 2017-04-26 View
510(k) K170678 Beta-CrossLaps CalCheck 5 JJX 2017-04-04 View
510(k) K163569 Elecsys CMV IgM LFZ 2017-03-17 View
510(k) K162840 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 MRG 2017-02-08 View
510(k) K162606 Elecsys TSH assay, cobas e 801 Immunoassay analyzer JLW 2017-01-23 View
510(k) K162895 Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 MMI 2017-01-18 View
510(k) K162173 Elecsys CYFRA 21-1 CalCheck 5 JJX 2017-01-12 View
510(k) DEN150057 Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 PQO 2016-12-19 View
510(k) K160915 Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker OVK 2016-12-14 View
510(k) K160910 Elecsys Syphilis LIP 2016-07-28 View
510(k) K153607 ROMA Calculation Tool Using Elecsys Assays ONX 2016-06-15 View
510(k) K160729 Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 PMT 2016-06-13 View
510(k) K152227 Elecsys Cortisol II, Cortisol II CalSet JFT 2016-04-27 View
510(k) K153301 Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II KXT 2016-04-08 View
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