Atlas FDA

Roche Diagnostics Corp.

357 FDA 510(k) clearances · PMA applicant

Sort:Newest firstOldest first

◉ Watch Roche Diagnostics Corp.

RecordFirmDate
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043)Roche Diagnostics Corp.2025-05-27
ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044)Roche Diagnostics Corp.2025-05-27
Elecsys Anti-HBc II (P100031/S033)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc II (P100032/S023)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM (P110031/S027)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM (P110022/S034)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBs (P010054/S048)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025)Roche Diagnostics Corp.2024-11-22
Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110022/S031)Roche Diagnostics Corp.2024-11-22
Elecsys total PSA Test System (P990056/S042)Roche Diagnostics Corp.2024-10-17
Elecsys free PSA Test System (P000027/S040)Roche Diagnostics Corp.2024-10-17
Elecsys free PSA Assay (P000027/S042)Roche Diagnostics Corp.2024-10-08
Elecsys Anti-HBc II / Elecsys Anti-HBc IgM (P110022/S033)Roche Diagnostics Corp.2024-10-03
Elecsys Anti-HBc IgM (P110031/S026)Roche Diagnostics Corp.2024-10-03
Elecsys Anti-HBc II / Elecsys Anti-HBc IgM (P100031/S032)Roche Diagnostics Corp.2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P010054/S047)Roche Diagnostics Corp.2024-10-03
Elecsys total PSA (P990056/S043)Roche Diagnostics Corp.2024-08-30
Elecsys free PSA (P000027/S041)Roche Diagnostics Corp.2024-08-30
Elecsys Anti-HBc II (P100031/S031)Roche Diagnostics Corp.2024-08-29
Elecsys Anti-HBs (P010054/S046)Roche Diagnostics Corp.2024-08-29
Elecsys Anti-HBc IgM (P110022/S032)Roche Diagnostics Corp.2024-08-29
Elecsys Anti-HBc IgM (P110022/S030)Roche Diagnostics Corp.2024-02-08
Elecsys Anti-HBs (P010054/S045)Roche Diagnostics Corp.2024-02-08
Elecsys Anti-HBc II (P100031/S030)Roche Diagnostics Corp.2024-02-08
Elecsys free PSA (P000027/S039)Roche Diagnostics Corp.2024-02-08
Elecsys total PSA (P990056/S041)Roche Diagnostics Corp.2024-02-08
Elecsys Anti-HBs, PreciControl Anti-HBs (P010054/S043)Roche Diagnostics Corp.2024-01-31
Elecsys Anti-HBs (P010054/S044)Roche Diagnostics Corp.2023-10-31
Elecsys Anti-HBc II (P100031/S029)Roche Diagnostics Corp.2023-10-31
Elecsys Anti-HBc IgM (P110022/S029)Roche Diagnostics Corp.2023-10-31
Elecsys free PSA (P990056/S040)Roche Diagnostics Corp.2023-10-05
Elecsys free PSA (P000027/S038)Roche Diagnostics Corp.2023-10-05
Elecsys Anti-HBc II (P100031/S028)Roche Diagnostics Corp.2023-05-08
Elecsys total PSA, total PSA CalSet II (P990056/S039)Roche Diagnostics Corp.2023-03-23
Elecsys free PSA, free PSA CalSet (P000027/S037)Roche Diagnostics Corp.2023-03-23
Elecsys Anti-HBc II (P100031/S027)Roche Diagnostics Corp.2022-04-04
Elecsys Anti-HBc II (P100032/S021)Roche Diagnostics Corp.2022-04-04
Elecsys Anti-HBs (P010054/S042)Roche Diagnostics Corp.2022-01-11
Elecsys Anti-HBc IgM Immunoassays (P110022/S028)Roche Diagnostics Corp.2022-01-11
Elecsys Anti-HBs (P010054/S041)Roche Diagnostics Corp.2021-12-16
Elecsys free PSA Test System (P000027/S036)Roche Diagnostics Corp.2021-11-16
Elecsys total PSA Test System (P990056/S038)Roche Diagnostics Corp.2021-11-16
Elecsys total PSA (P990056/S037)Roche Diagnostics Corp.2020-05-12
Elecsys free PSA Test System, Biotin remediation (P000027/S035)Roche Diagnostics Corp.2020-05-12
Elecsys total PSA Test System (P990056/S036)Roche Diagnostics Corp.2019-05-03
Elecsys free PSA Test System (P000027/S034)Roche Diagnostics Corp.2019-05-03
Elecsys total PSA (P990056/S035)Roche Diagnostics Corp.2019-04-24
Elecsys Anti-HBc II (P100032/S020)Roche Diagnostics Corp.2019-04-24
Elecsys Anti-HBc II (P100031/S026)Roche Diagnostics Corp.2019-04-24
Elecsys Anti-HBs (P010054/S040)Roche Diagnostics Corp.2019-04-24
Elecsys Anti-HCV Immunoassay (P090007/S020)Roche Diagnostics Corp.2019-04-24
Elecsys free PSA (P000027/S033)Roche Diagnostics Corp.2019-04-24
Elecsys Anti-HCV Immunoassay (P090009/S018)Roche Diagnostics Corp.2019-04-24
Elecsys Anti-HBc IgM (P110022/S027)Roche Diagnostics Corp.2019-04-24
Elecsys Anti-HBc IgM (P110025/S023)Roche Diagnostics Corp.2019-04-24
Elecsys Anti-HBc IgM (P110031/S024)Roche Diagnostics Corp.2019-04-24
Elecsys HBsAg Immunoassay (P990012/S033)Roche Diagnostics Corp.2019-04-24
Elecsys Anti-HCV Immunoassay (P090008/S021)Roche Diagnostics Corp.2019-04-24
Elecsys Anti-HBs; PreciControl Anti-HBs; Anti-HBs CalCheck (P010054/S038)Roche Diagnostics Corp.2019-04-15
Elecsys Anti-HBc II (P100032/S019)Roche Diagnostics Corp.2018-11-06
Elecsys Anti-HBc II (P100031/S025)Roche Diagnostics Corp.2018-11-06
Elecsys ANti-HBs (P010054/S039)Roche Diagnostics Corp.2018-11-06
Elecsys Anti-HBc IgM (P110022/S026)Roche Diagnostics Corp.2018-11-06
Elecsys Anti-HBc IgM (P110031/S023)Roche Diagnostics Corp.2018-11-06
Elecsys Anti-HBc IgM (P110025/S022)Roche Diagnostics Corp.2018-11-06
Elecsys total PSA (P990056/S034)Roche Diagnostics Corp.2018-10-25
Elecsys free PSA Test System (P000027/S032)Roche Diagnostics Corp.2018-10-25
Elecsys free PSA, free PSA CalSet, and free PSA CalCheck (P000027/S027)Roche Diagnostics Corp.2018-07-27
Elecsys Ani-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck (P010054/S037)Roche Diagnostics Corp.2018-07-13
Elecsys total PSA and total PSA CalSet II (P990056/S028)Roche Diagnostics Corp.2018-07-09
Elecsys HBsAg Immunoassay (P990012/S032)Roche Diagnostics Corp.2018-06-13
Elecsys Anti-HCV Immunoassay (P090008/S020)Roche Diagnostics Corp.2018-06-13
Elecsys free PSA (P000027/S031)Roche Diagnostics Corp.2018-06-13
Elecsys Anti-HBc II (P100031/S024)Roche Diagnostics Corp.2018-06-13
Elecsys Anti-HBc IgM (P110022/S025)Roche Diagnostics Corp.2018-06-13
Elecsys total PSA (P990056/S033)Roche Diagnostics Corp.2018-06-13
Elecsys Anti-HBs (P010054/S036)Roche Diagnostics Corp.2018-06-13
Elecsys Anti-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck (P010054/S034)Roche Diagnostics Corp.2018-05-17
Elecsys Total PSA, Total PSA CalSet ll (P990056/S032)Roche Diagnostics Corp.2018-05-03
Elecsys Anti-HBc IgM (P110031/S022)Roche Diagnostics Corp.2018-04-20
Elecsys Anti-HBs Immunoassay (P010054/S035)Roche Diagnostics Corp.2018-04-20
Elecsys total PSA (P990056/S031)Roche Diagnostics Corp.2018-04-20
Elecsys Anbti-HCV Immunoassay (P090007/S019)Roche Diagnostics Corp.2018-04-20
Elecsys Anti-HBc II (P100032/S018)Roche Diagnostics Corp.2018-04-20
Elecsys HBsAg Immunoassay (P990012/S031)Roche Diagnostics Corp.2018-04-20
Elecsys Anti-HBc II (P100031/S023)Roche Diagnostics Corp.2018-04-20
Elecsys free PSA (P000027/S030)Roche Diagnostics Corp.2018-04-20
Elecsys Anti-HBc II, PreciControl Anti-HBc (P100031/S020)Roche Diagnostics Corp.2018-02-09
Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110022/S022)Roche Diagnostics Corp.2017-12-21
Elecsys total PSA (P990056/S029)Roche Diagnostics Corp.2017-12-20
Elecsys Anti-HCV Immunoassay (P090009/S017)Roche Diagnostics Corp.2017-12-20
Elecsys Anti-HCV Immunoassay (P090008/S019)Roche Diagnostics Corp.2017-12-20
Elecsys Anti-HBs (P010054/S032)Roche Diagnostics Corp.2017-12-20
Elecsys HBsAg Immunoassay (P990012/S029)Roche Diagnostics Corp.2017-12-20
Elecsys Anti-HBc II (P100032/S017)Roche Diagnostics Corp.2017-12-20
Elecsys free PSA (P000027/S028)Roche Diagnostics Corp.2017-12-20
Elecsys Anti-HBc IgM (P110022/S024)Roche Diagnostics Corp.2017-12-20
Elecsys Anti-HBc IgM (P110025/S021)Roche Diagnostics Corp.2017-12-20
Elecsys Anti-HCV Immunoassay (P090007/S017)Roche Diagnostics Corp.2017-12-20
Elecsys Anti-HBc II (P100031/S021)Roche Diagnostics Corp.2017-12-20
Next →

Track Roche Diagnostics Corp. automatically

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