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Roche Diagnostics Corp.

357 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Elecsys Anti-HBc IgM (P110031/S020)Roche Diagnostics Corp.2017-12-20
Elecsys Anti-HBc (P100031/S019)Roche Diagnostics Corp.2017-08-31
Elecsys Anit-HCV (P090008/S018)Roche Diagnostics Corp.2017-08-31
Elecsys Anit-HBs (P010054/S031)Roche Diagnostics Corp.2017-08-31
Elecsys Anit-HCV (P090007/S016)Roche Diagnostics Corp.2017-08-31
Elecsys HBsAg (P990012/S028)Roche Diagnostics Corp.2017-08-31
Elecsys Anit-HBc IgM (P110031/S019)Roche Diagnostics Corp.2017-08-31
Elecsys Anit-HBc IgM (P110025/S020)Roche Diagnostics Corp.2017-08-31
Elecsys Anit-HCV (P090009/S016)Roche Diagnostics Corp.2017-08-31
Elecsys Anit-HBc IgM (P110022/S023)Roche Diagnostics Corp.2017-08-31
Elecsys Free PSA Immunoassay (P000027/S026)Roche Diagnostics Corp.2017-08-31
Elesys Total PSA Immunoassay (P990056/S027)Roche Diagnostics Corp.2017-08-31
Elecsys Anti-HBc (P100032/S016)Roche Diagnostics Corp.2017-08-31
Elecsys Anti-HBc Immunoassay test system (P100031/S017)Roche Diagnostics Corp.2017-08-16
Elecsys Anti-HBC Immunoassay test system (P100032/S014)Roche Diagnostics Corp.2017-08-16
Elecsys Anti-HBc IgM Immunoassay (P110025/S019)Roche Diagnostics Corp.2017-06-23
Elecsys free PSA Immunoassay (P000027/S025)Roche Diagnostics Corp.2017-06-23
Elecsys total PSA (100/200 tests) Immunoassay (P990056/S026)Roche Diagnostics Corp.2017-06-23
Elecsys Anti-HBc Immunoassay (P100031/S018)Roche Diagnostics Corp.2017-06-23
Elecsys Anti-HBc Immunoassay (P100032/S015)Roche Diagnostics Corp.2017-06-23
Elecsys Anti-HBc IgM Immunoassay (P110022/S021)Roche Diagnostics Corp.2017-06-23
Elecsys Anti-HBs Immunoassay (P010054/S030)Roche Diagnostics Corp.2017-06-23
Elecsys Anti-HBc IgM Immunoassay (P110031/S018)Roche Diagnostics Corp.2017-06-23
Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM (P110025/S017)Roche Diagnostics Corp.2017-03-03
Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM (P110022/S019)Roche Diagnostics Corp.2017-03-03
Elecsys Anti-HBc IgM, PreciControl Anti-HBc IgM (P110031/S016)Roche Diagnostics Corp.2017-03-03
Elecsys free PSA, free PSA Calset, free PSA CalCheck (P000027/S023)Roche Diagnostics Corp.2017-03-02
Elecsys total PSA, total PSA CalSet II (P990056/S024)Roche Diagnostics Corp.2017-03-02
COBAS E 601 (P110022/S020)Roche Diagnostics Corp.2017-02-28
COBAS E 411 (P110031/S017)Roche Diagnostics Corp.2017-02-28
MODULAR ANALYSTICS E170 (P110025/S018)Roche Diagnostics Corp.2017-02-28
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110022/S018)Roche Diagnostics Corp.2016-12-14
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110031/S015)Roche Diagnostics Corp.2016-12-14
ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM (P110025/S016)Roche Diagnostics Corp.2016-12-14
ELECSYS FREE PSA (P000027/S024)Roche Diagnostics Corp.2016-11-22
ELECSYS HBSAG (P990012/S027)Roche Diagnostics Corp.2016-11-22
ELECSYS ANTI-HBS (P010054/S029)Roche Diagnostics Corp.2016-11-22
ELECSYS TOTAL PSA (P990056/S025)Roche Diagnostics Corp.2016-11-22
ELECSYS ANTI-HBC IMMUNOASSAY (P100032/S011)Roche Diagnostics Corp.2016-08-08
ELECSYS HBSAG IMMUNOASSAY (P990012/S024)Roche Diagnostics Corp.2016-08-08
ELECSYS ANTI-HBC IGM IMMUNOASSAY (P110022/S015)Roche Diagnostics Corp.2016-08-08
Elecsys Anti-HBc II, PreciControl Anti-HBc (P100031/S014)Roche Diagnostics Corp.2016-08-08
ELECSYS ANTI-HBC IGM IMMUNOASSAY (P110025/S013)Roche Diagnostics Corp.2016-08-08
ELECSYS ANTI-HBC IGM IMMUNOASSAY (P110031/S012)Roche Diagnostics Corp.2016-08-08
ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S026)Roche Diagnostics Corp.2016-08-08
ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER (P090007/S015)Roche Diagnostics Corp.2016-03-16
ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG (P990012/S026)Roche Diagnostics Corp.2016-03-16
ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S023)Roche Diagnostics Corp.2016-03-16
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S022)Roche Diagnostics Corp.2016-03-16
ELECSYS ANTI-HBS (P010054/S028)Roche Diagnostics Corp.2016-03-16
ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA (P110025/S015)Roche Diagnostics Corp.2016-03-16
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER (P090009/S015)Roche Diagnostics Corp.2016-03-16
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER (P090008/S017)Roche Diagnostics Corp.2016-03-16
ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC (P100031/S016)Roche Diagnostics Corp.2016-03-16
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110022/S017)Roche Diagnostics Corp.2016-03-16
ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER (P100032/S013)Roche Diagnostics Corp.2016-03-16
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110031/S014)Roche Diagnostics Corp.2016-03-16
ELECSYS ANTI-HBC TEST SYSTEM (P100031/S015)Roche Diagnostics Corp.2016-02-24
ELECSYS HBSAG TEST SYSTEM (P990012/S025)Roche Diagnostics Corp.2016-02-24
ELECSYS ANTI-HBC TEST SYSTEM (P100032/S012)Roche Diagnostics Corp.2016-02-24
ELECSYS ANTI-HBC IGM TEST SYSTEM (P110022/S016)Roche Diagnostics Corp.2016-02-24
ELECSYS ANTI-HBC IGM TEST SYSTEM (P110025/S014)Roche Diagnostics Corp.2016-02-24
ELECSYS ANTI-HCV TEST SYSTEM (P090009/S014)Roche Diagnostics Corp.2016-02-24
ELECSYS ANTI-HBS TEST SYSTEM (P010054/S027)Roche Diagnostics Corp.2016-02-24
ELECSYS ANTI-HCV TEST SYSTEM (P090008/S016)Roche Diagnostics Corp.2016-02-24
ELECSYS ANTI-HBC IGM TEST SYSTEM (P110031/S013)Roche Diagnostics Corp.2016-02-24
ELECSYS ANTI-HCV TEST SYSTEM (P090007/S014)Roche Diagnostics Corp.2016-02-24
ELECSYS ANTI-HBC-IGM (P110025/S012)Roche Diagnostics Corp.2015-11-24
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S022)Roche Diagnostics Corp.2015-11-24
ELECSYS ANTI-HCV (P090008/S015)Roche Diagnostics Corp.2015-11-24
ELECSYS ANTI-HBC (P100032/S010)Roche Diagnostics Corp.2015-11-24
ELECSYS ANTI-HCV (P090009/S013)Roche Diagnostics Corp.2015-11-24
ELECSYS ANTI-HBC-IGM (P110031/S011)Roche Diagnostics Corp.2015-11-24
ELECSYS FREE PSA IMMUNOASSAY (P000027/S021)Roche Diagnostics Corp.2015-11-24
ELECSYS ANTI-HBS (P010054/S025)Roche Diagnostics Corp.2015-11-24
ELECSYS ANTI-HBC-IGM (P110022/S014)Roche Diagnostics Corp.2015-11-24
ELECSYS ANTI-HBC (P100031/S013)Roche Diagnostics Corp.2015-11-24
ELECSYS ANTI-HCV (P090007/S013)Roche Diagnostics Corp.2015-11-24
ELECSYS HBSAG (P990012/S023)Roche Diagnostics Corp.2015-11-24
ELECSYS HBSAG CONFIRMATORY TEST (P990012/S022)Roche Diagnostics Corp.2014-12-22
ELECSYS FREE PSA CALCHECK (P000027/S020)Roche Diagnostics Corp.2014-12-22
ELECSYS ANTI-HBS CALCHECK (P010054/S024)Roche Diagnostics Corp.2014-12-22
ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170 (P110025/S011)Roche Diagnostics Corp.2014-11-26
ELECSYS ANTI-HBC IGM ON COBAS E 601 (P110022/S013)Roche Diagnostics Corp.2014-11-26
ELECSYS ANTI-HBC ON COBAS E 601 (P100031/S012)Roche Diagnostics Corp.2014-11-26
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411 (P090007/S012)Roche Diagnostics Corp.2014-09-19
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 AND COBAS E 602 (P090008/S014)Roche Diagnostics Corp.2014-09-19
ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E 170 (P090009/S012)Roche Diagnostics Corp.2014-09-19
ELECSYS ANTI-HBC (P100031/S011)Roche Diagnostics Corp.2014-06-12
ELECSYS ANTI-HBS (P010054/S023)Roche Diagnostics Corp.2014-06-12
ELECSYS FREE PSA (P000027/S019)Roche Diagnostics Corp.2014-06-12
ELECSYS TOTAL PSA (P990056/S021)Roche Diagnostics Corp.2014-06-12
ELECSYS HBS AG (P990012/S021)Roche Diagnostics Corp.2014-06-12
ELESYS ANTI-HBC IGM (P110022/S012)Roche Diagnostics Corp.2014-06-12
ELECSYS ANTI-HCV (P090008/S013)Roche Diagnostics Corp.2014-06-12
ELECSYS HBSAG IMMUNOASSAY (P990012/S020)Roche Diagnostics Corp.2014-03-21
ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S022)Roche Diagnostics Corp.2014-03-21
ELECSYS FREE PSA IMMUNOASSAY (P000027/S018)Roche Diagnostics Corp.2014-03-21
ELECSYS ANTI-HBC IMMUNOASSAY (P100032/S009)Roche Diagnostics Corp.2014-03-21
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S020)Roche Diagnostics Corp.2014-03-21
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Every clearance here is in the API, with alerts when new ones post.