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Roche Diagnostics Corp.

357 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC (P100031)Roche Diagnostics Corp.2011-06-22
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S011)Roche Diagnostics Corp.2011-06-20
ELECSYS FREE PSA IMMUNOASSAY (P000027/S009)Roche Diagnostics Corp.2011-06-20
ELECSYS FREE PSA IMMUNOASSAY (P000027/S010)Roche Diagnostics Corp.2011-05-24
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S012)Roche Diagnostics Corp.2011-05-24
ELECSYS ANTI-HCV IMMUNOASSAY (P090007/S002)Roche Diagnostics Corp.2011-05-04
ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S013)Roche Diagnostics Corp.2011-05-04
ELECSYS ANTI-HCV IMMUNOASSAY (P090009/S002)Roche Diagnostics Corp.2011-05-04
ELECSYS ANTI-HCV IMMUNOASSAY (P090008/S002)Roche Diagnostics Corp.2011-05-04
ELECSYS HBSAG IMMUNOASSAY (P990012/S008)Roche Diagnostics Corp.2011-05-04
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 411 IMMUNOASSAY ANALYZER (P090007/S001)Roche Diagnostics Corp.2010-09-23
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER (P090009/S001)Roche Diagnostics Corp.2010-09-23
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 601 IMMUNOASSAY ANALYZER (P090008/S001)Roche Diagnostics Corp.2010-09-23
ELECSYS FREE PSA CALCHECK (P000027/S008)Roche Diagnostics Corp.2010-06-08
ELECSYS ANTI-HBS CALCHECK (P010054/S012)Roche Diagnostics Corp.2010-06-04
ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER (P090007)Roche Diagnostics Corp.2010-04-29
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER (P090008)Roche Diagnostics Corp.2010-04-29
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER (P090009)Roche Diagnostics Corp.2010-04-29
ELECSYS ANTI-HBS TEST SYSTEM (P010054/S011)Roche Diagnostics Corp.2010-01-07
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S010)Roche Diagnostics Corp.2009-12-03
ELECSYS FREE PSA IMMUNOASSAY, PSA CALSET & PSA CALCHECK (P000027/S005)Roche Diagnostics Corp.2009-03-03
ELECSYS TOTAL PSA IMMUNOASSAY AND ELECYS TOTAL PSA CALSET (P990056/S007)Roche Diagnostics Corp.2008-11-18
ELECSYS HBSAG TEST SYSTEM (P990012/S005)Roche Diagnostics Corp.2008-11-13
ELECSYS ANTI-HBS TEST SYSTEM (P010054/S007)Roche Diagnostics Corp.2008-11-13
ELECSYS HBSAG TEST SYSTEM (P990012/S006)Roche Diagnostics Corp.2008-10-30
ELECSYS ANTI-HBS TEST SYSTEM (P010054/S008)Roche Diagnostics Corp.2008-10-30
ELECSYS TOTAL PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER (P990056/S008)Roche Diagnostics Corp.2008-10-17
ELECSYS FREE PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER (P000027/S006)Roche Diagnostics Corp.2008-10-17
ELECSYS HBSAG IMMUNOASSAY (P990012/S007)Roche Diagnostics Corp.2008-09-23
ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S010)Roche Diagnostics Corp.2008-09-23
ELECSYS TOTAL PSA (P990056/S009)Roche Diagnostics Corp.2008-09-17
ELECSYS FREE PSA (P000027/S007)Roche Diagnostics Corp.2008-09-17
ELECSYS ANTI-HBS CALCHECK (P010054/S009)Roche Diagnostics Corp.2008-07-09
ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS (P010054/S001)Roche Diagnostics Corp.2007-03-13
ROCHE ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFORMATORY TEST AND PRECICONTROL HBSAG (P990012/S001)Roche Diagnostics Corp.2007-03-13
ELECSYS ANTI-HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS (P010054/S003)Roche Diagnostics Corp.2007-03-13
ELECSYS TOTAL PSA CALSET (P990056/S006)Roche Diagnostics Corp.2007-01-19
ELECSYS FREE PSA CALSET AND (P000027/S004)Roche Diagnostics Corp.2007-01-19
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S004)Roche Diagnostics Corp.2006-10-13
ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S003)Roche Diagnostics Corp.2006-08-10
ELECSYS ANTI-HBS IMMUNOASSAY TEST SYSTEM (P010054/S005)Roche Diagnostics Corp.2006-07-28
ELECSYS AND HBS IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBS (P010054/S004)Roche Diagnostics Corp.2006-06-30
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S002)Roche Diagnostics Corp.2006-04-12
ELECSYS HBSAG TEST SYSTEM (P990012/S003)Roche Diagnostics Corp.2005-11-09
ELECSYS ANTI-HBS,ELECSYS PRECICONTROL ANTI-HBS (P010054/S002)Roche Diagnostics Corp.2005-10-06
ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY TEST AND ELECSYS PRECICONTROL HBSAG (P990012/S002)Roche Diagnostics Corp.2005-09-22
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHEK (P000027/S002)Roche Diagnostics Corp.2003-02-24
ELSECSYS FREE PSA IMMUNOASSAY,FREE PSA CALSET,FREE PSA CALCHECK (P000027/S001)Roche Diagnostics Corp.2002-04-29
ELECSYS ANTI-HBS (P010054)Roche Diagnostics Corp.2002-02-28
ELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSET (P990056/S001)Roche Diagnostics Corp.2002-02-08
ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG (P990012)Roche Diagnostics Corp.2001-06-01
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027)Roche Diagnostics Corp.2000-12-12
ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056)Roche Diagnostics Corp.2000-11-22
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Every clearance here is in the API, with alerts when new ones post.