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Roche Diagnostics

19 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01
Elecsys Anti-HBe (P190005/S004)Roche Diagnostics2024-02-08
Elecsys Anti-HBs II (P190034/S006)Roche Diagnostics2024-02-08
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S003)Roche Diagnostics2024-01-31
Elecsys Anti-HBe (P190005/S003)Roche Diagnostics2023-10-31
Elecsys Anti-HBs II (P190034/S004)Roche Diagnostics2023-10-31
Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck (P190034/S002)Roche Diagnostics2023-06-13
Elecsys Anti-HBe, PreciControl Anti-HBe (P190005/S002)Roche Diagnostics2023-05-16
Elecsys Anti-HBs II (P190034/S001)Roche Diagnostics2021-12-16
Elecsys Anti-HBe, PreciControl Anti-HBe (P190005/S001)Roche Diagnostics2021-11-01
Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck (P190034)Roche Diagnostics2021-02-23
Elecsys Anti-HBe, PreciControl Anti-HBe (P190005)Roche Diagnostics2021-02-03

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Every clearance here is in the API, with alerts when new ones post.