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Roche Diagnostics Corp.

357 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
ELECSYS ANTI-HBC TEST SYSTEM (P100031/S008)Roche Diagnostics Corp.2013-12-20
ELECSYS ANTI-HBC IGM TEST SYSTEM (P110022/S008)Roche Diagnostics Corp.2013-12-20
ELECSYS ANTI-HBC TEST SYSTEM (P100032/S007)Roche Diagnostics Corp.2013-12-19
ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC (P100031/S009)Roche Diagnostics Corp.2013-08-12
ELECSYS ANTI-HBC IGM ASSAY (MODULAR ANALYTICS E170 ANALYZER) (P110025/S010)Roche Diagnostics Corp.2013-08-06
ELECSYS ANTI-HBC IGM ASSAY (COBAS E 601 ANALYZER) (P110022/S011)Roche Diagnostics Corp.2013-08-06
ELECSYS ANTI-HBC IGM ASSAY (COBAS E 411 ANALYZER) (P110031/S010)Roche Diagnostics Corp.2013-08-06
ELECSCYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG, ELECSYS HBSAG CONFIRMATORY TEST (P990012/S016)Roche Diagnostics Corp.2013-05-14
ELECSYS FREE PSA CALSET (P000027/S017)Roche Diagnostics Corp.2013-04-10
ELECSYS TOTAL PSA CALSET (P990056/S019)Roche Diagnostics Corp.2012-12-26
ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 601) AND PRECICONTROL ANTI-HCV (P090008/S012)Roche Diagnostics Corp.2012-12-20
ELECSYS ANTI-HCV ON COBAS E 411 (P090007/S007)Roche Diagnostics Corp.2012-12-20
ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170 (P100031/S005)Roche Diagnostics Corp.2012-12-20
ELECSYS HBSAG (P990012/S013)Roche Diagnostics Corp.2012-12-20
PRECICONTROL ANTI-HBC IGM (COBAS E 411) (P110031/S008)Roche Diagnostics Corp.2012-12-20
PRECICONTROL ANTI-HBC (ELECSYS) 2010 (P100032/S008)Roche Diagnostics Corp.2012-12-20
PRECICONTROL HBSAG (P990012/S019)Roche Diagnostics Corp.2012-12-20
ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 411) AND PRECICONTROL ANTI-HCV (P090007/S011)Roche Diagnostics Corp.2012-12-20
ELECSYS ANTI-HBC IGM ON COBAS E 601 (P110022/S002)Roche Diagnostics Corp.2012-12-20
ELECSYS ANTI-HCV ON COBAS E 601 (P090008/S008)Roche Diagnostics Corp.2012-12-20
ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170 (P090009/S007)Roche Diagnostics Corp.2012-12-20
ELECSYS ANTI-HBC ON ELECSYS 2010 (P100032/S005)Roche Diagnostics Corp.2012-12-20
ELECSYS ANTI-HBS (P010054/S018)Roche Diagnostics Corp.2012-12-20
ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170 (P110025/S002)Roche Diagnostics Corp.2012-12-20
PRECICONTROL ANTI-HBC IGM (MODULAR ANALYTICS E170) (P110025/S008)Roche Diagnostics Corp.2012-12-20
ELECSYS ANTI-HBC IGM ON COBAS E 411 (P110031/S002)Roche Diagnostics Corp.2012-12-20
PRECICONTROL ANTI-HBS (P010054/S021)Roche Diagnostics Corp.2012-12-20
PRECICONTROL ANTI-HBC (MODULAR ANALYTICS E170) (P100031/S010)Roche Diagnostics Corp.2012-12-20
ELECSYS ANTI-HCV IMMUNOASSAY (MODULAR ANALYTICS E170) AND PRECICONTROL ANTI-HCV (P090009/S011)Roche Diagnostics Corp.2012-12-20
PRECICONTROL ANTI-HBC IGM (COBAS E 601) (P110022/S009)Roche Diagnostics Corp.2012-12-20
ELECSYS TOTAL PSA (P990056/S016)Roche Diagnostics Corp.2012-12-18
ELECSYS FREE PSA (P000027/S014)Roche Diagnostics Corp.2012-12-18
ELECSYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG AND ELECSYS HBSAG CONFIRMATORY TEST SYSTEM (P990012/S018)Roche Diagnostics Corp.2012-11-02
ELECSYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG AND ELECSYS HBSAG CONFIRMATORY TEST SYSTEM (P990012/S017)Roche Diagnostics Corp.2012-11-02
ELECSYS ANTI-HCV IMMUNOASSAY ON CABAS E 411 (P090007/S010)Roche Diagnostics Corp.2012-10-04
ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E170 (P090009/S010)Roche Diagnostics Corp.2012-10-04
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 (P090008/S011)Roche Diagnostics Corp.2012-10-04
ELECSYS ANTI-HBC-IGM ON COBAS E 411 (P110031/S001)Roche Diagnostics Corp.2012-06-18
ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170 (P110025/S001)Roche Diagnostics Corp.2012-06-18
ELECSYS ANTI-HBC-IGM ON COBAS E 601 (P110022/S001)Roche Diagnostics Corp.2012-06-18
ELECSYS ANTI-HCV IMMUNOASSAY (P090008/S006)Roche Diagnostics Corp.2012-04-25
ELECSYS ANTI-HBS (ANTI-HBS) TEST SYSTEM (P010054/S017)Roche Diagnostics Corp.2012-04-23
ELECSYS HBSAG (P990012/S014)Roche Diagnostics Corp.2012-03-28
ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170 (P100031/S006)Roche Diagnostics Corp.2012-03-28
ELECSYS ANTI-HBS (P010054/S019)Roche Diagnostics Corp.2012-03-28
ELECSYS ANTI-HCV ON COBAS E 601 (P090008/S009)Roche Diagnostics Corp.2012-03-28
ELECSYS ANTI-HBC IGM ON MODULAR ANALYTICS E170 (P110025/S006)Roche Diagnostics Corp.2012-03-28
ELECSYS ANTI-HBC IGM ON COBAS E 601 (P110022/S006)Roche Diagnostics Corp.2012-03-28
ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170 (P090009/S008)Roche Diagnostics Corp.2012-03-28
ELECSYS ANTI-HBC ON ELECSYS 2010 (P100032/S006)Roche Diagnostics Corp.2012-03-28
ELECSYS TOTAL PSA (P990056/S017)Roche Diagnostics Corp.2012-03-28
ELECSYS ANTI-HCV ON COBAS E 411 (P090007/S008)Roche Diagnostics Corp.2012-03-28
ELECSYS FREE PSA (P000027/S015)Roche Diagnostics Corp.2012-03-28
ELECSYS ANTI-HBC IGM ON COBAS E 411 (P110031/S006)Roche Diagnostics Corp.2012-03-28
ELECSYS HBSAG (HBSAG) TEST SYSTEM (P990012/S012)Roche Diagnostics Corp.2012-03-19
ELECSYS ANTI-HBC-IGM ON COBAS E 411 (P110031/S003)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170 (P110025/S005)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON COBAS E 411 (P110031/S005)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON COBAS E 601 (P110022/S005)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON COBAS E 601 (P110022/S003)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170 (P110025/S003)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170 (P110025/S004)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON COBAS E 601 (P110022/S004)Roche Diagnostics Corp.2012-02-27
ELECSYS ANTI-HBC-IGM ON COBAS E 411 (P110031/S004)Roche Diagnostics Corp.2012-02-27
ELECSYS TOTAL PSA (TPSA) TEST SYSTEM (P990056/S014)Roche Diagnostics Corp.2012-02-24
ELECSYS FREE PSA (FPSA) TEST SYSTEM (P000027/S012)Roche Diagnostics Corp.2012-02-24
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110031)Roche Diagnostics Corp.2012-01-03
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S015)Roche Diagnostics Corp.2011-12-21
ELECSYS FREE PSA IMMUNOASSAY (P000027/S013)Roche Diagnostics Corp.2011-12-21
ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA (P110025)Roche Diagnostics Corp.2011-12-14
ELECSYS ANTI-HCV IMMUNOASSAY COBAS E 601 (P090008/S007)Roche Diagnostics Corp.2011-12-14
ELECSYS ANTI-HCV IMMUNOASSAY ON MUDULAR ANALYTICS (P090009/S006)Roche Diagnostics Corp.2011-12-14
ELECSYS ANTI-HCV INMMUNOASSAY ON COBAS E 411 (P090007/S006)Roche Diagnostics Corp.2011-12-14
ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYTICS E170 (P090009/S005)Roche Diagnostics Corp.2011-11-17
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411 (P090007/S005)Roche Diagnostics Corp.2011-11-17
ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S016)Roche Diagnostics Corp.2011-11-17
ELECSYS ANTI-HBC IMMUNOASSAY ON ELECSYS 2010 (P100032/S004)Roche Diagnostics Corp.2011-11-17
ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYTICS E170 (P100031/S004)Roche Diagnostics Corp.2011-11-17
ELECSYS HBSAG IMMUNOASSAY (P990012/S011)Roche Diagnostics Corp.2011-11-17
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 601 (P090008/S005)Roche Diagnostics Corp.2011-11-17
ELECSYS HBSAG IMMUNOASSAY (P990012/S010)Roche Diagnostics Corp.2011-11-16
ELECSYS ANTI-HCV IMMUNOASSAY ON COBAS E 411 (P090007/S004)Roche Diagnostics Corp.2011-11-16
ELECSYS ANTI-HBC IMMUNOASSAY ON ELECSYS 2010 (P100032/S002)Roche Diagnostics Corp.2011-11-16
ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYSTICS E170 (P100031/S002)Roche Diagnostics Corp.2011-11-16
ELECSYS ANTI-HCV IMMUNOASSAY ON MODULAR ANALYSTICS E170 (P090009/S004)Roche Diagnostics Corp.2011-11-16
ELECSYS ANTI -HCV IMMUNOASSAY ON COBAS E 601 (P090008/S004)Roche Diagnostics Corp.2011-11-16
ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM (P110022)Roche Diagnostics Corp.2011-10-26
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S013)Roche Diagnostics Corp.2011-09-23
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON E170 IMMUNOASSAY ANALYZER (P090009/S003)Roche Diagnostics Corp.2011-09-23
ELECSYS ANTI-HBS IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBS (P010054/S014)Roche Diagnostics Corp.2011-09-23
ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYSTICS E170 IMMUNOASSAY ANALYZER (P100031/S003)Roche Diagnostics Corp.2011-09-23
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 (P090007/S003)Roche Diagnostics Corp.2011-09-23
ELECSYS FREE PSA IMMUNOASSAY (P000027/S011)Roche Diagnostics Corp.2011-09-23
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 (P090008/S003)Roche Diagnostics Corp.2011-09-23
ELECSYS HBSAG IMMUNOASSAY & CONFIRMATORY & PRECICONTROL HBSAG (P990012/S009)Roche Diagnostics Corp.2011-09-23
ELECSYS ANTI-HBC IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER (P100032/S003)Roche Diagnostics Corp.2011-09-23
ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S015)Roche Diagnostics Corp.2011-08-08
ELECSYS ANTI-HBC IMMUNOASSAY (P100031/S001)Roche Diagnostics Corp.2011-07-22
ELECSYS ANTI-HBC IMMUNOASSAY (P100032/S001)Roche Diagnostics Corp.2011-07-22
ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER (P100032)Roche Diagnostics Corp.2011-06-27
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Every clearance here is in the API, with alerts when new ones post.