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Roche Molecular Systems, Inc.

644 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
cobas HPV Test (P100020/S044)Roche Molecular Systems, Inc.2019-05-03
cobas HCV (P150015/S025)Roche Molecular Systems, Inc.2019-05-03
cobas HCV Test (P150015/S024)Roche Molecular Systems, Inc.2019-04-25
COBAS AmpliPrep/COBAS TaqMan HBV, v2.0 (P050028/S074)Roche Molecular Systems, Inc.2019-04-10
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S073)Roche Molecular Systems, Inc.2019-04-10
COBAS® AmpliPrep/COBAS TaqMan CV Test (P110037/S045)Roche Molecular Systems, Inc.2019-04-10
cobas 4800 HPV Master Mix (P100020/S043)Roche Molecular Systems, Inc.2019-03-11
cobas HPV Test (P100020/S042)Roche Molecular Systems, Inc.2019-01-02
cobas HBV (P150014/S023)Roche Molecular Systems, Inc.2019-01-02
cobas CMV (P160041/S016)Roche Molecular Systems, Inc.2019-01-02
COBAS AmpliPrep/COBAS TaqMan HCV Test (P060030/S072)Roche Molecular Systems, Inc.2019-01-02
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S044)Roche Molecular Systems, Inc.2019-01-02
COBAS AmpliPrep/COBAS TaqMan HBV Test (P050028/S073)Roche Molecular Systems, Inc.2019-01-02
cobas HCV (P150015/S023)Roche Molecular Systems, Inc.2019-01-02
cobas BRAF V600 Mutation Test (P110020/S031)Roche Molecular Systems, Inc.2018-12-13
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure System (P060030/S071)Roche Molecular Systems, Inc.2018-12-13
cobas CMV (P160041/S015)Roche Molecular Systems, Inc.2018-12-13
cobas KRAS Mutation Test (P140023/S019)Roche Molecular Systems, Inc.2018-12-13
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System (P050028/S072)Roche Molecular Systems, Inc.2018-12-13
cobas HCV (P150015/S022)Roche Molecular Systems, Inc.2018-12-13
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S043)Roche Molecular Systems, Inc.2018-12-13
cobas HBV (P150014/S022)Roche Molecular Systems, Inc.2018-12-13
cobas HPV Test (P100020/S041)Roche Molecular Systems, Inc.2018-12-11
cobas HBV (P150014/S021)Roche Molecular Systems, Inc.2018-12-07
cobas HPV Test (P100020/S040)Roche Molecular Systems, Inc.2018-12-07
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System (P050028/S071)Roche Molecular Systems, Inc.2018-12-07
cobas HCV (P150015/S021)Roche Molecular Systems, Inc.2018-12-07
cobas BRAF V600 Mutation Test (P110020/S030)Roche Molecular Systems, Inc.2018-12-07
cobas KRAS Mutation Test (P140023/S018)Roche Molecular Systems, Inc.2018-12-07
cobas CMV (P160041/S014)Roche Molecular Systems, Inc.2018-12-07
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S042)Roche Molecular Systems, Inc.2018-12-07
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV TEst, v2.0 for use on the High Pure System (P060030/S070)Roche Molecular Systems, Inc.2018-12-07
cobas HPV Test (P100020/S039)Roche Molecular Systems, Inc.2018-11-23
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure System (P060030/S069)Roche Molecular Systems, Inc.2018-09-19
cobas HPV Test (P100020/S038)Roche Molecular Systems, Inc.2018-09-19
cobas HBV (P150014/S020)Roche Molecular Systems, Inc.2018-09-19
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S041)Roche Molecular Systems, Inc.2018-09-19
cobas HCV (P150015/S020)Roche Molecular Systems, Inc.2018-09-19
cobas CMV (P160041/S013)Roche Molecular Systems, Inc.2018-09-19
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System (P050028/S070)Roche Molecular Systems, Inc.2018-09-19
cobas BRAF V600 Mutation Test (P110020/S029)Roche Molecular Systems, Inc.2018-09-19
cobas KRAS Mutation Test (P140023/S017)Roche Molecular Systems, Inc.2018-09-19
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure System (P060030/S068)Roche Molecular Systems, Inc.2018-08-17
cobas HCV (P150015/S018)Roche Molecular Systems, Inc.2018-08-17
cobas CMV (P160041/S012)Roche Molecular Systems, Inc.2018-08-17
cobas HBV (P150014/S019)Roche Molecular Systems, Inc.2018-08-17
Roche COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System (P050028/S069)Roche Molecular Systems, Inc.2018-08-17
cobas HPV Test (P100020/S037)Roche Molecular Systems, Inc.2018-08-17
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S040)Roche Molecular Systems, Inc.2018-08-17
cobas BRAF V600 Mutation Test (P110020/S028)Roche Molecular Systems, Inc.2018-08-17
cobas KRAS Mutation Test (P140023/S016)Roche Molecular Systems, Inc.2018-08-17
cobas x 480, cobas HPV Test, 240/960 Tests (P100020/S032)Roche Molecular Systems, Inc.2018-08-08
COBAS TaqMan HBV Test for use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S068)Roche Molecular Systems, Inc.2018-07-26
Cobas BRAF V600 Mutation Test (P110020/S027)Roche Molecular Systems, Inc.2018-07-26
Cobas HPV Test (P100020/S036)Roche Molecular Systems, Inc.2018-07-26
Cobas HCV (P150015/S017)Roche Molecular Systems, Inc.2018-07-26
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S067)Roche Molecular Systems, Inc.2018-07-26
Cobas HBV (P150014/S018)Roche Molecular Systems, Inc.2018-07-26
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S039)Roche Molecular Systems, Inc.2018-07-26
Cobas CMV (P160041/S011)Roche Molecular Systems, Inc.2018-07-26
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S066)Roche Molecular Systems, Inc.2018-07-05
cobas HPV Test (P100020/S035)Roche Molecular Systems, Inc.2018-07-05
cobas BRAF V600 Mutation Test (P110020/S026)Roche Molecular Systems, Inc.2018-07-05
cobas KRAS Mutation Test (P140023/S015)Roche Molecular Systems, Inc.2018-07-05
cobas CMV (P160041/S010)Roche Molecular Systems, Inc.2018-07-05
COBAS TaqMan HBV Test for Use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S067)Roche Molecular Systems, Inc.2018-07-05
cobas HCV (P150015/S016)Roche Molecular Systems, Inc.2018-07-05
cobas HBV (P150014/S017)Roche Molecular Systems, Inc.2018-07-05
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S038)Roche Molecular Systems, Inc.2018-07-05
Roche cobas KRAS Mutation Test, Roche cobas DNA Sample Preparation Kit (P140023/S014)Roche Molecular Systems, Inc.2018-07-03
COBAS TaqMan HCV Test, v2.0, For use with the High Pure System, High Pure System Viral Nucleic Acid Kit (P060030/S065)Roche Molecular Systems, Inc.2018-07-03
cobas HBV Test (P150014/S016)Roche Molecular Systems, Inc.2018-07-03
cobas HCV Test (P150015/S015)Roche Molecular Systems, Inc.2018-07-03
COBAS TaqMan HBV Test, High Pure System Viral Nucleic Acid Kit (P050028/S066)Roche Molecular Systems, Inc.2018-07-03
cobas HPV Test, 240/960 Tests (P100020/S034)Roche Molecular Systems, Inc.2018-07-03
Roche cobas DNA Sample Preparation Kit, Roche cobas 4800 BRAF V600 Mutation Test (P110020/S025)Roche Molecular Systems, Inc.2018-07-03
cobas CMV Test for use on the cobas 6800/8800 System (P160041/S009)Roche Molecular Systems, Inc.2018-07-03
COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test (P110037/S037)Roche Molecular Systems, Inc.2018-07-03
cobas HPV Test, 240 Tests (P100020/S025)Roche Molecular Systems, Inc.2018-07-02
Roche CBAS TaqMan HBV Test, v2.0 (P050028/S065)Roche Molecular Systems, Inc.2018-06-14
cobas HPV Test, 240/960 Tests (P100020/S033)Roche Molecular Systems, Inc.2018-06-12
cobas HPV Test (P100020/S031)Roche Molecular Systems, Inc.2018-06-01
Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S035)Roche Molecular Systems, Inc.2018-05-15
Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.0 (P060030/S063)Roche Molecular Systems, Inc.2018-05-15
Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 (P050028/S064)Roche Molecular Systems, Inc.2018-05-15
Cobas HPV Test (P100020/S030)Roche Molecular Systems, Inc.2018-05-15
Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 (P050028/S062)Roche Molecular Systems, Inc.2018-05-15
Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 (P050028/S063)Roche Molecular Systems, Inc.2018-05-04
Cobas HCV (P150015/S014)Roche Molecular Systems, Inc.2018-05-04
Cobas HBV (P150014/S015)Roche Molecular Systems, Inc.2018-05-04
Cobas CMV (P160041/S008)Roche Molecular Systems, Inc.2018-05-04
Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S036)Roche Molecular Systems, Inc.2018-05-04
Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.0 (P060030/S064)Roche Molecular Systems, Inc.2018-05-04
Cobas 4800 BRAF V600 Mutation Test (P110020/S024)Roche Molecular Systems, Inc.2018-03-27
Cobas KRAS Mutation Test (P140023/S013)Roche Molecular Systems, Inc.2018-03-27
Cobas HPV Test (P100020/S029)Roche Molecular Systems, Inc.2018-03-26
Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S034)Roche Molecular Systems, Inc.2018-03-26
Cobas CMV Test (P160041/S007)Roche Molecular Systems, Inc.2018-03-26
Cobas AmpliPrep/Cobas TaqMan HCV Test, v.20 (P060030/S062)Roche Molecular Systems, Inc.2018-03-26
Cobas TaqMan HBV Test, Cobas AmpliPep/Cobas, TaqMan HBV Test, v2.0, Cobas AmpliPrep (P050028/S061)Roche Molecular Systems, Inc.2018-03-26
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