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Roche Diagnostics Corp.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories4
Latest FDA decision2026-04-29
TypeNumberDevice NameCodeDateActions
PMA P000027 PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERSLTJ2026-04-29 View
PMA P990056 Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerMTF2026-04-29 View
PMA P110022 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-05-22 View
PMA P110031 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-05-22 View
PMA P010054 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-05-22 View
PMA P100032 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-05-22 View
PMA P100031 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2025-05-22 View
PMA P110025 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2019-04-24 View
PMA P990012 Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM2019-04-24 View
PMA P090009 Assay, enzyme linked immunosorbent, hepatitis c virusMZO2019-04-24 View
PMA P090007 Assay, enzyme linked immunosorbent, hepatitis c virusMZO2019-04-24 View
PMA P090008 Assay, enzyme linked immunosorbent, hepatitis c virusMZO2019-04-24 View
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