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Roche Molecular Systems, Inc.

644 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
COBAS AMPLIPREP / COBAS TAQMAN CMV TEST, V2.0 (P110037/S003)Roche Molecular Systems, Inc.2013-01-07
COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S028)Roche Molecular Systems, Inc.2013-01-02
COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/BOBAS TAQMAN HCV TEST (P060030/S030)Roche Molecular Systems, Inc.2013-01-02
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S004)Roche Molecular Systems, Inc.2012-11-19
COBAS HPV TEST (P100020/S005)Roche Molecular Systems, Inc.2012-11-19
COBAS HPV TEST (P100020/S007)Roche Molecular Systems, Inc.2012-11-06
COBAS HPV TEST (P100020/S002)Roche Molecular Systems, Inc.2012-10-18
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S040)Roche Molecular Systems, Inc.2012-10-10
COBAS AMPLIPREP/COBAS TAQMAN HCV V2.0 TEST FOR USE WITH THE HIGH PURE SYSTEM (P060030/S029)Roche Molecular Systems, Inc.2012-10-10
COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST FOR USE WITH THE HIGH PURE SYSTEM (P050028/S027)Roche Molecular Systems, Inc.2012-10-10
COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S023)Roche Molecular Systems, Inc.2012-09-18
COBAS AMPLICOR HCV TEST, V2.0/COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0 (P000012/S036)Roche Molecular Systems, Inc.2012-09-18
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST/COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM, V2.0 (P060030/S024)Roche Molecular Systems, Inc.2012-09-18
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S005)Roche Molecular Systems, Inc.2012-09-14
COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S002)Roche Molecular Systems, Inc.2012-09-14
COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST, HIGH PURE/COBAS TAQMAN HBV TEST (P050028/S026)Roche Molecular Systems, Inc.2012-09-14
COBAS HPV TEST (P100020/S006)Roche Molecular Systems, Inc.2012-09-14
COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST (P060030/S028)Roche Molecular Systems, Inc.2012-09-14
COBAS AMPLICOR HCV TEST, V2.0, COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S039)Roche Molecular Systems, Inc.2012-09-14
COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S001)Roche Molecular Systems, Inc.2012-09-05
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S003)Roche Molecular Systems, Inc.2012-09-04
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S015)Roche Molecular Systems, Inc.2012-07-12
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S016)Roche Molecular Systems, Inc.2012-07-12
COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037)Roche Molecular Systems, Inc.2012-07-05
COBAS AMPLIPREP / COBAS TAQMAN HBV TEST, V2.0 (P050028/S025)Roche Molecular Systems, Inc.2012-06-29
COBAS AMPLIPREP / COBAS TAQMAN HCV TEST (P060030/S026)Roche Molecular Systems, Inc.2012-06-29
COBAS AMPLIPREP / COBAS AMPLICOR HCV V2.0 AND COBAS AMPLICOR HCV TEST, V2.0 (P000012/S038)Roche Molecular Systems, Inc.2012-06-07
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM (P060030/S025)Roche Molecular Systems, Inc.2012-06-07
COBAS HPV TEST (P100020/S003)Roche Molecular Systems, Inc.2012-06-07
COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM AND COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S024)Roche Molecular Systems, Inc.2012-06-07
ROCHE COBAS TAQMAN HBV TESTS (P050028/S020)Roche Molecular Systems, Inc.2012-03-20
COBAS TAQMAN HCV TESTS (P060030/S021)Roche Molecular Systems, Inc.2012-03-20
COBAS AMPLICOR HCV TEST V2.0, COBAS AMPLIPREP/ COBAS AMPLICOR HCV TEST, V2.0 (P000012/S033)Roche Molecular Systems, Inc.2012-01-11
AMPLICOR HCV TEST (P000010/S024)Roche Molecular Systems, Inc.2012-01-11
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 AND COBAS TAQMAN HBV TEST (P050028/S019)Roche Molecular Systems, Inc.2011-12-29
COBAS AMPLICOR HCV TEST, V2.0 (P000012/S031)Roche Molecular Systems, Inc.2011-12-29
COBAS HPV TEST (P100020/S001)Roche Molecular Systems, Inc.2011-12-29
AMPLICOR HCV TEST V2.0 (P000010/S022)Roche Molecular Systems, Inc.2011-12-29
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST AND COBAS TAQMAN HCV TEST (P060030/S020)Roche Molecular Systems, Inc.2011-12-29
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S002)Roche Molecular Systems, Inc.2011-10-26
ROCHE COBAS 4800 BRAF V600 MUTATION TEST (P110020/S001)Roche Molecular Systems, Inc.2011-10-17
AMPLICOR HCV TEST V2.0 & COBAS AMPLICOR HCV TEST V2.0 (P000010/S025)Roche Molecular Systems, Inc.2011-10-11
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S023)Roche Molecular Systems, Inc.2011-10-11
COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM (P050028/S022)Roche Molecular Systems, Inc.2011-10-11
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0 (P000012/S035)Roche Molecular Systems, Inc.2011-10-11
COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S021)Roche Molecular Systems, Inc.2011-09-30
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S034)Roche Molecular Systems, Inc.2011-09-29
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S022)Roche Molecular Systems, Inc.2011-09-22
COBAS 4800 BRAF V600 MUTATION TEST (P110020)Roche Molecular Systems, Inc.2011-08-17
AMPLICOR HCV TEST (P000010/S019)Roche Molecular Systems, Inc.2011-08-17
AMPLICOR HCV TEST (P000010/S023)Roche Molecular Systems, Inc.2011-08-09
COBAS AMPLICOR HCV TEST (P000012/S032)Roche Molecular Systems, Inc.2011-08-09
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S017)Roche Molecular Systems, Inc.2011-07-07
COBAS AMPLICOR HCV TEST/COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S027)Roche Molecular Systems, Inc.2011-06-27
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S011)Roche Molecular Systems, Inc.2011-06-24
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S026)Roche Molecular Systems, Inc.2011-05-24
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S018)Roche Molecular Systems, Inc.2011-05-05
COBAS HPV TEST (P100020)Roche Molecular Systems, Inc.2011-04-19
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S017)Roche Molecular Systems, Inc.2011-03-22
AMPLICOR HCV TEST V2.0/COBAS AMPLICOR HCV TEST V2.0 (P000010/S020)Roche Molecular Systems, Inc.2011-03-22
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0 (P000012/S029)Roche Molecular Systems, Inc.2011-03-22
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S016)Roche Molecular Systems, Inc.2011-03-22
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S013)Roche Molecular Systems, Inc.2011-02-24
COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM (P060030/S015)Roche Molecular Systems, Inc.2011-02-24
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S028)Roche Molecular Systems, Inc.2010-12-10
AMPLICOR HCV/COBAS AMPLICOR HCV TEST (P000010/S018)Roche Molecular Systems, Inc.2010-12-10
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V.2.0 (P050028/S012)Roche Molecular Systems, Inc.2010-12-07
AMPLICOR HCV TEST (P000010/S017)Roche Molecular Systems, Inc.2010-09-23
COBAS AMPLIPREP/COBAS AMPLICOR HVC TEST (P000012/S025)Roche Molecular Systems, Inc.2010-09-23
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S014)Roche Molecular Systems, Inc.2010-09-22
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S004)Roche Molecular Systems, Inc.2010-09-09
COBAS TAQMAN HCV TEST VERSION 2.0 (P060030/S006)Roche Molecular Systems, Inc.2010-09-01
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S012)Roche Molecular Systems, Inc.2010-08-30
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S008)Roche Molecular Systems, Inc.2010-08-30
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S010)Roche Molecular Systems, Inc.2010-06-15
AMPLICOR HCV TEST, VERSION 2.0 (P000010/S015)Roche Molecular Systems, Inc.2010-04-08
COBAS TAQMAN HBV TEST (P050028/S006)Roche Molecular Systems, Inc.2010-04-08
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S007)Roche Molecular Systems, Inc.2010-04-08
COBAS AMPLICOR HCV TEST AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST VERSION 2.0 (P000012/S022)Roche Molecular Systems, Inc.2010-04-08
AMPLICOR HCV TEST (P000010/S016)Roche Molecular Systems, Inc.2010-04-07
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S009)Roche Molecular Systems, Inc.2010-03-24
COBAS AMPLICOR HCV TEST (P000012/S024)Roche Molecular Systems, Inc.2010-03-24
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S023)Roche Molecular Systems, Inc.2010-03-08
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S008)Roche Molecular Systems, Inc.2010-02-04
COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM (P050028/S007)Roche Molecular Systems, Inc.2010-02-04
COBAS AMPLIPREP / COBAS TAQMAN HCV TEST (P060030/S005)Roche Molecular Systems, Inc.2009-10-13
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S004)Roche Molecular Systems, Inc.2009-07-30
AMPLICOR HCV TEST (P000010/S014)Roche Molecular Systems, Inc.2009-07-30
COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM (P050028/S005)Roche Molecular Systems, Inc.2009-07-30
COBAS AMPLICOR HCV TEST/COBAS AMPLIPREP (P000012/S021)Roche Molecular Systems, Inc.2009-07-30
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S003)Roche Molecular Systems, Inc.2009-05-22
COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S020)Roche Molecular Systems, Inc.2009-01-14
AMPLICOR HCV TEST VERSION 2.0 (P000010/S013)Roche Molecular Systems, Inc.2009-01-14
COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM (P050028/S003)Roche Molecular Systems, Inc.2008-12-22
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S019)Roche Molecular Systems, Inc.2008-12-22
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S002)Roche Molecular Systems, Inc.2008-12-22
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S001)Roche Molecular Systems, Inc.2008-12-04
ROCHE MOLECULAR SYSTEMS COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S018)Roche Molecular Systems, Inc.2008-12-04
COBAS TAQMAN HBV TEST (P050028/S002)Roche Molecular Systems, Inc.2008-11-25
AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST (P940040/S010)Roche Molecular Systems, Inc.2008-11-25
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Every clearance here is in the API, with alerts when new ones post.