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Roche Molecular Systems, Inc.

644 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
COBAS TAQMAN HBV TEST (P050028/S001)Roche Molecular Systems, Inc.2008-11-12
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030)Roche Molecular Systems, Inc.2008-10-30
COBAS TAQMAN HBV TEST (P050028)Roche Molecular Systems, Inc.2008-09-04
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S009)Roche Molecular Systems, Inc.2008-08-26
AMPLICOR HCV TEST (P000010/S012)Roche Molecular Systems, Inc.2008-08-26
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S017)Roche Molecular Systems, Inc.2008-08-26
COBAS AMPLICOR HCV TEST (P000012/S016)Roche Molecular Systems, Inc.2008-08-26
COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S014)Roche Molecular Systems, Inc.2008-02-06
AMPLICOR HCV TEST, VERSION 2.0 (P000010/S010)Roche Molecular Systems, Inc.2008-02-06
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S008)Roche Molecular Systems, Inc.2008-01-11
COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST (P000012/S015)Roche Molecular Systems, Inc.2008-01-11
AMPLICOR HEPATITIS C VIRUS (HCV) TEST (P000010/S011)Roche Molecular Systems, Inc.2008-01-11
COBAS AMPLICOR HCV TEST VERSION 2.0 (P000012/S013)Roche Molecular Systems, Inc.2007-08-30
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S007)Roche Molecular Systems, Inc.2007-08-30
AMPLICOR HCV TEST VERSION 2.0 (P000010/S009)Roche Molecular Systems, Inc.2007-08-30
COBAS AMPLICOR HEPTATIS C VIRUS (HCV) TEST (P000012/S012)Roche Molecular Systems, Inc.2007-02-28
AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0 (P000010/S007)Roche Molecular Systems, Inc.2006-06-22
COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, V2.0 (P000012/S009)Roche Molecular Systems, Inc.2006-06-16
COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 (P000012/S007)Roche Molecular Systems, Inc.2006-02-17
AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 (P000010/S006)Roche Molecular Systems, Inc.2006-02-17
AMPLICOR HCV TEST, V2.0 (P000010/S005)Roche Molecular Systems, Inc.2006-01-25
COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S006)Roche Molecular Systems, Inc.2006-01-25
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S008)Roche Molecular Systems, Inc.2006-01-25
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S006)Roche Molecular Systems, Inc.2005-12-14
AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S005)Roche Molecular Systems, Inc.2005-04-22
AMPLICOR HCV, TEST VERSION 2.0 (P000010/S004)Roche Molecular Systems, Inc.2005-04-22
COBAS AMPLICOR HCV TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S005)Roche Molecular Systems, Inc.2005-04-22
COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S004)Roche Molecular Systems, Inc.2004-11-04
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S003)Roche Molecular Systems, Inc.2004-08-30
AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST (P940040/S004)Roche Molecular Systems, Inc.2004-06-23
AMPLICOR HCV TEST,VERSION 2.0 (P000010/S003)Roche Molecular Systems, Inc.2004-05-06
AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST (P940040/S003)Roche Molecular Systems, Inc.2004-04-22
COBAS AMPLICOR HCV TEST, V2.0 (P000012/S001)Roche Molecular Systems, Inc.2001-10-12
COBAS AMPLICOR HCV TEST, V2.0 (P000010/S001)Roche Molecular Systems, Inc.2001-10-12
AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0 (P000010)Roche Molecular Systems, Inc.2001-07-05
COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0 (P000012)Roche Molecular Systems, Inc.2001-07-03
ROCHE AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST (P940040/S001)Roche Molecular Systems, Inc.2000-09-12
AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST (P940040)Roche Molecular Systems, Inc.1996-11-26
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