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Roche Molecular Systems, Inc.

644 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
COBAS KRAS MUTATION TEST (P140023/S003)Roche Molecular Systems, Inc.2016-04-25
COBAS HCV TEST (P150015/S001)Roche Molecular Systems, Inc.2016-03-24
COBAS HBV TEST (P150014/S001)Roche Molecular Systems, Inc.2016-03-24
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0 (P060030/S048)Roche Molecular Systems, Inc.2016-02-18
COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST, V2.0 (P060030/S049)Roche Molecular Systems, Inc.2016-02-09
COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST (P110037/S024)Roche Molecular Systems, Inc.2016-02-09
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S048)Roche Molecular Systems, Inc.2016-02-09
COBAS AMPLICOR HCV TEST VERSION 2.0 (P000012/S054)Roche Molecular Systems, Inc.2015-10-15
COBAS HCV TEST (P150015)Roche Molecular Systems, Inc.2015-10-14
COBAS HBV TEST (P150014)Roche Molecular Systems, Inc.2015-10-14
ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT (P140023/S002)Roche Molecular Systems, Inc.2015-09-24
COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST (P110037/S022)Roche Molecular Systems, Inc.2015-07-23
ROCHE COBAS DNA SAMPLE PREPARATION KIT, ROCHE COBAS 4800 BRAF V600 MUTATION TEST (P110020/S014)Roche Molecular Systems, Inc.2015-07-23
ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT (P140023/S001)Roche Molecular Systems, Inc.2015-07-23
COBAS TAQMAN HBV TEST, HIGH PURE SYSTEM VIRAL NUCLEIC ACID KIT (P050028/S047)Roche Molecular Systems, Inc.2015-07-23
COBAS HPC TEST,240 TESTS AND COBAS HPV TEST, 960 TESTS (P100020/S015)Roche Molecular Systems, Inc.2015-07-23
COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S021)Roche Molecular Systems, Inc.2015-05-08
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S046)Roche Molecular Systems, Inc.2015-05-08
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0 (P060030/S047)Roche Molecular Systems, Inc.2015-05-08
COBAS KRAS MUTATION TEST (P140023)Roche Molecular Systems, Inc.2015-05-07
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 (P060030/S045)Roche Molecular Systems, Inc.2015-05-01
COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S019)Roche Molecular Systems, Inc.2015-05-01
COBAS HPV TEST (P100020/S013)Roche Molecular Systems, Inc.2015-05-01
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S044)Roche Molecular Systems, Inc.2015-05-01
COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM, CONAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S045)Roche Molecular Systems, Inc.2015-04-09
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, COBAS TAQMAN HCV TEST,V2.0 FOR USE WITH THE HIGH PURE SYSTEM (P060030/S046)Roche Molecular Systems, Inc.2015-04-09
COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S020)Roche Molecular Systems, Inc.2015-04-09
COBAS HPV TEST (P100020/S014)Roche Molecular Systems, Inc.2015-04-09
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S013)Roche Molecular Systems, Inc.2015-04-09
COBAS AMPLICOR HCV TEST , VERSION 2.0 (P000012/S053)Roche Molecular Systems, Inc.2015-04-09
COBAS AMPLIPREP/COBAS TAQ/MAN CYTOMEGALOVIRUS TEST (P110037/S016)Roche Molecular Systems, Inc.2015-03-26
COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S018)Roche Molecular Systems, Inc.2015-01-15
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S012)Roche Molecular Systems, Inc.2015-01-15
COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST VERSION 2.0 (P000012/S052)Roche Molecular Systems, Inc.2015-01-15
COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM COBAS AMPLIPREP/COBAS TAQMAN HCV V2.0 (P060030/S044)Roche Molecular Systems, Inc.2015-01-14
COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S051)Roche Molecular Systems, Inc.2015-01-14
COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S043)Roche Molecular Systems, Inc.2015-01-14
COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S017)Roche Molecular Systems, Inc.2015-01-14
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0, COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S050)Roche Molecular Systems, Inc.2014-12-04
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 (P060030/S043)Roche Molecular Systems, Inc.2014-08-22
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S042)Roche Molecular Systems, Inc.2014-04-28
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S042)Roche Molecular Systems, Inc.2014-04-28
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S049)Roche Molecular Systems, Inc.2014-04-28
COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST (P110037/S015)Roche Molecular Systems, Inc.2014-04-28
COBAS HPV TEST (P100020/S008)Roche Molecular Systems, Inc.2014-04-24
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S041)Roche Molecular Systems, Inc.2014-04-04
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 (P060030/S041)Roche Molecular Systems, Inc.2014-04-04
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0 (P000012/S048)Roche Molecular Systems, Inc.2014-04-04
COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST (P110037/S014)Roche Molecular Systems, Inc.2014-04-04
COMBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 (P050028/S040)Roche Molecular Systems, Inc.2014-03-18
COBAS AMPLIPREP/COMBAS TAQMAN HCV TEST V2.0 (P060030/S040)Roche Molecular Systems, Inc.2014-03-18
COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S013)Roche Molecular Systems, Inc.2014-03-18
COBAS BRAF V600 MUTATION TEST (P110020/S010)Roche Molecular Systems, Inc.2014-03-12
COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST, V2.0 (P060030/S039)Roche Molecular Systems, Inc.2014-03-04
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0,COBAS AMPLIPREP/COBAS TAQMAN WASH REAGENT (P050028/S039)Roche Molecular Systems, Inc.2014-01-23
COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST (P050028/S038)Roche Molecular Systems, Inc.2014-01-09
COBAS AMPLICOR HCV TEST V2.0 (P000012/S047)Roche Molecular Systems, Inc.2014-01-09
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S011)Roche Molecular Systems, Inc.2014-01-09
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S038)Roche Molecular Systems, Inc.2014-01-09
COBAS HPV TEST, 240 TESTS; COBAS HPV TEST 960 TESTS (P100020/S012)Roche Molecular Systems, Inc.2013-12-16
COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST (P110037/S012)Roche Molecular Systems, Inc.2013-11-26
COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S011)Roche Molecular Systems, Inc.2013-10-09
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S036)Roche Molecular Systems, Inc.2013-10-09
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S037)Roche Molecular Systems, Inc.2013-10-09
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S046)Roche Molecular Systems, Inc.2013-10-09
AMPHLIPRE/COBAS TAQMAN HBV TEST (P050028/S036)Roche Molecular Systems, Inc.2013-10-09
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S045)Roche Molecular Systems, Inc.2013-10-09
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S037)Roche Molecular Systems, Inc.2013-10-09
AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S010)Roche Molecular Systems, Inc.2013-10-09
COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S009)Roche Molecular Systems, Inc.2013-09-12
COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM, COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST (P050028/S035)Roche Molecular Systems, Inc.2013-09-12
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, COBAS TAQMAN HCV TEST, V 2.0 FOR USE WITH THE HIGH PURE SYSTEM (P060030/S035)Roche Molecular Systems, Inc.2013-09-12
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S009)Roche Molecular Systems, Inc.2013-09-12
COBAS HPV TEST (P100020/S011)Roche Molecular Systems, Inc.2013-09-12
COBAS AMPLICOR HCV TEST, COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0 (P000012/S044)Roche Molecular Systems, Inc.2013-09-12
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S008)Roche Molecular Systems, Inc.2013-09-06
COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PRESSURE SYSTEM, COBAS AMPLIPREP/COBAS TAQMAN HBV TEST (P050028/S034)Roche Molecular Systems, Inc.2013-09-06
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST VERSION 2.0, COBAS TAQMAN HCV TEST VERSION 2.0 FOR USE WITH THE HIGH PURE SYSTEM (P060030/S034)Roche Molecular Systems, Inc.2013-09-06
COBAS AMPLIPREP/COBAS TAQMAN CMV TEST (P110037/S008)Roche Molecular Systems, Inc.2013-09-06
COBAS HPV TEST (P100020/S010)Roche Molecular Systems, Inc.2013-09-06
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST,V2.0,; HIGH PURE/COBAS TAQMAN HCV V20.3 TEST (P060030/S033)Roche Molecular Systems, Inc.2013-08-21
COBAS AMPLIPREP/CONAS TAQMAN CMV TEST (P110037/S007)Roche Molecular Systems, Inc.2013-08-21
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S007)Roche Molecular Systems, Inc.2013-08-21
COBAS HPV TEST (P100020/S009)Roche Molecular Systems, Inc.2013-08-21
ROCHE COBAS HPV TEST (P100020/S004)Roche Molecular Systems, Inc.2013-06-25
COBAS TAQMAN HBV FOR USE WITH THE HIGH PURE SYSTEM (P050028/S033)Roche Molecular Systems, Inc.2013-06-24
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0 (P000012/S043)Roche Molecular Systems, Inc.2013-06-24
COBAS AMPLICOR HCV TEST V2.0,COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S042)Roche Molecular Systems, Inc.2013-06-07
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST,V2.0 (P050028/S032)Roche Molecular Systems, Inc.2013-06-06
COBAS AMPLIPREP/COBRA TAQMAN CMV TEST (P110037/S006)Roche Molecular Systems, Inc.2013-06-06
COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0 (P000012/S041)Roche Molecular Systems, Inc.2013-06-06
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST V2.0 (P060030/S032)Roche Molecular Systems, Inc.2013-06-06
CCOBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S031)Roche Molecular Systems, Inc.2013-05-07
COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 (P050028/S030)Roche Molecular Systems, Inc.2013-05-03
COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST (P110037/S005)Roche Molecular Systems, Inc.2013-03-21
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0 (P060030/S027)Roche Molecular Systems, Inc.2013-02-14
COBAS AMPLIPREP / COBAS TAQMAN HCV TEST (P060030/S031)Roche Molecular Systems, Inc.2013-02-11
COBAS AMPLIPREP / COBAS TAQMAN CMV TEST (P110037/S004)Roche Molecular Systems, Inc.2013-02-11
COBAS AMPLIPREP / COBAS TAQMAN HBV TEST, V2.0 (P050028/S029)Roche Molecular Systems, Inc.2013-02-11
ROCHE COBAS DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190 (P110020/S006)Roche Molecular Systems, Inc.2013-01-10
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Every clearance here is in the API, with alerts when new ones post.