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Roche Molecular Systems, Inc.

644 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
cobas HCV (P150015/S042)Roche Molecular Systems, Inc.2020-12-10
cobas HPV (P190028/S004)Roche Molecular Systems, Inc.2020-12-10
cobas HBV (P150014/S040)Roche Molecular Systems, Inc.2020-12-10
cobas HBV (P150014/S037)Roche Molecular Systems, Inc.2020-11-02
cobas HCV (P150015/S039)Roche Molecular Systems, Inc.2020-11-02
cobas HPV (P190028/S003)Roche Molecular Systems, Inc.2020-10-07
cobas HBV (P150014/S039)Roche Molecular Systems, Inc.2020-10-07
cobas CMV (P160041/S031)Roche Molecular Systems, Inc.2020-10-07
cobas HCV (P150015/S041)Roche Molecular Systems, Inc.2020-10-07
cobas 4800 HPV Test (P100020/S053)Roche Molecular Systems, Inc.2020-08-26
cobas KRAS Mutation Test (P140023/S023)Roche Molecular Systems, Inc.2020-08-26
cobas HBV (P150014/S038)Roche Molecular Systems, Inc.2020-08-26
cobas HCV (P150015/S040)Roche Molecular Systems, Inc.2020-08-26
Roche COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S083)Roche Molecular Systems, Inc.2020-08-26
cobas HPV Test (P190028/S002)Roche Molecular Systems, Inc.2020-08-26
cobas BRAF V600 Mutation Test (P110020/S035)Roche Molecular Systems, Inc.2020-08-26
cobas CMV (P160041/S030)Roche Molecular Systems, Inc.2020-08-26
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S084)Roche Molecular Systems, Inc.2020-08-26
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S054)Roche Molecular Systems, Inc.2020-08-26
cobas HPV Mg/Mn (P100020/S052)Roche Molecular Systems, Inc.2020-06-24
cobas KRAS Mutation Test (P140023/S022)Roche Molecular Systems, Inc.2020-05-18
cobas HPV Test (P100020/S051)Roche Molecular Systems, Inc.2020-05-14
cobas HBV (P150014/S036)Roche Molecular Systems, Inc.2020-05-14
COBAS® TaqMan® HBV Test for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0 (P050028/S082)Roche Molecular Systems, Inc.2020-05-14
COBAS® TaqMan® HCV Test, v2.0, for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test, v2.0 (P060030/S083)Roche Molecular Systems, Inc.2020-05-14
cobas HCV (P150015/S038)Roche Molecular Systems, Inc.2020-05-14
cobas CMV (P160041/S029)Roche Molecular Systems, Inc.2020-05-14
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S053)Roche Molecular Systems, Inc.2020-05-14
cobas HPV (P190028/S001)Roche Molecular Systems, Inc.2020-05-05
cobas HPV for use on the cobas 6800/8800 Systems (P190028)Roche Molecular Systems, Inc.2020-04-03
cobas HPV Test (P100020/S049)Roche Molecular Systems, Inc.2020-03-04
Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 (P050028/S081)Roche Molecular Systems, Inc.2020-02-20
Cobas AmpliPrep/Cobas Taqman HCV Test v2.0 (P060030/S082)Roche Molecular Systems, Inc.2020-02-20
Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S052)Roche Molecular Systems, Inc.2020-02-20
cobas CMV (P160041/S028)Roche Molecular Systems, Inc.2020-02-06
cobas HBV (P150014/S035)Roche Molecular Systems, Inc.2020-02-06
cobas HCV (P150015/S037)Roche Molecular Systems, Inc.2020-02-06
COBAS HBV TEST (P150014/S034)Roche Molecular Systems, Inc.2019-12-18
COBAS CMV TEST (P160041/S027)Roche Molecular Systems, Inc.2019-12-18
COBAS HCV TEST (P150015/S036)Roche Molecular Systems, Inc.2019-12-18
Cobas HBV (P150014/S030)Roche Molecular Systems, Inc.2019-12-11
Cobas CMV (P160041/S023)Roche Molecular Systems, Inc.2019-12-11
Cobas HCV (P150015/S032)Roche Molecular Systems, Inc.2019-12-11
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S080)Roche Molecular Systems, Inc.2019-11-05
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S051)Roche Molecular Systems, Inc.2019-11-05
COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 (P060030/S081)Roche Molecular Systems, Inc.2019-11-05
cobas HBV Test (P150014/S033)Roche Molecular Systems, Inc.2019-10-10
Cobas TaqMan HCV Test, v2.0, for Use with the High Pure System and Cobas AmpliPrep, Cobas TaqMan HCV Test, v2.0 (P060030/S080)Roche Molecular Systems, Inc.2019-10-10
cobas BRAF V600 Mutation Test (P110020/S034)Roche Molecular Systems, Inc.2019-10-10
cobas HPV Test (P100020/S050)Roche Molecular Systems, Inc.2019-10-10
cobas CMV Test (P160041/S026)Roche Molecular Systems, Inc.2019-10-10
cobas HCV Test (P150015/S035)Roche Molecular Systems, Inc.2019-10-10
cobas KRAS Mutation Test (P140023/S021)Roche Molecular Systems, Inc.2019-10-10
Cobas TaqMan HBV Test for Use with the High Pure System and Cobas AmpliPrep, CobasTaqMan HBV Test, v2.0 (P050028/S079)Roche Molecular Systems, Inc.2019-10-10
Cobas AmpliPrep and Cobas TaqMan CMV Test (P110037/S050)Roche Molecular Systems, Inc.2019-10-10
cobas HBV (P150014/S032)Roche Molecular Systems, Inc.2019-09-26
cobas CMV (P160041/S025)Roche Molecular Systems, Inc.2019-09-26
cobas HCV (P150015/S034)Roche Molecular Systems, Inc.2019-09-26
cobas 4800 BRAF V600 Mutation Test (P110020/S033)Roche Molecular Systems, Inc.2019-09-25
COBAS AmpliPrep/COBAS TaqMan HCV Test V2.0 (P060030/S079)Roche Molecular Systems, Inc.2019-09-12
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S078)Roche Molecular Systems, Inc.2019-09-12
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S049)Roche Molecular Systems, Inc.2019-09-12
cobas HBV Test (P150014/S031)Roche Molecular Systems, Inc.2019-09-04
Cobas CMV (P160041/S024)Roche Molecular Systems, Inc.2019-09-04
cobas HCV (P150015/S033)Roche Molecular Systems, Inc.2019-09-04
cobas HPV (P100020/S048)Roche Molecular Systems, Inc.2019-09-03
cobas AmpliPrep/cobas TaqMan CMV Test (P110037/S048)Roche Molecular Systems, Inc.2019-08-13
cobas AmpliPrep/cobas TaqMan HBV Test, v2 (P050028/S077)Roche Molecular Systems, Inc.2019-08-13
cobas AmpliPrep/cobas TaqMan HCV Test, v2 (P060030/S078)Roche Molecular Systems, Inc.2019-08-13
COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 (P060030/S077)Roche Molecular Systems, Inc.2019-06-13
Cobas HCV (P150015/S030)Roche Molecular Systems, Inc.2019-06-06
Cobas CMV (P160041/S022)Roche Molecular Systems, Inc.2019-06-06
Cobas HCV (P150015/S031)Roche Molecular Systems, Inc.2019-06-06
Cobas HBV (P150014/S028)Roche Molecular Systems, Inc.2019-06-06
Cobas CMV (P160041/S021)Roche Molecular Systems, Inc.2019-06-06
Cobas HBV (P150014/S029)Roche Molecular Systems, Inc.2019-06-06
Cobas HBV Test (P150014/S026)Roche Molecular Systems, Inc.2019-05-24
Cobas HCV Test (P150015/S029)Roche Molecular Systems, Inc.2019-05-24
Cobas CMV (P160041/S020)Roche Molecular Systems, Inc.2019-05-24
cobas HPV Test (P100020/S047)Roche Molecular Systems, Inc.2019-05-22
cobas BRAF v600 Muttaion Test (P110020/S032)Roche Molecular Systems, Inc.2019-05-22
COBAS TaqMan HBV Test for use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S076)Roche Molecular Systems, Inc.2019-05-22
cobas KRAS Mutation Test (P140023/S020)Roche Molecular Systems, Inc.2019-05-22
cobas HBV (P150014/S027)Roche Molecular Systems, Inc.2019-05-22
COBAS TaqMan HCV Test, v2.0, for use with the High Pure System and COBAS AMpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S076)Roche Molecular Systems, Inc.2019-05-22
cobas HCV (P150015/S028)Roche Molecular Systems, Inc.2019-05-22
COBAS® AmliPrep/COBAS® TaqMan® CMV Test (P110037/S047)Roche Molecular Systems, Inc.2019-05-22
cobas CMV (P160041/S019)Roche Molecular Systems, Inc.2019-05-22
Cobas CMV Test (P160041/S018)Roche Molecular Systems, Inc.2019-05-09
Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.0 (P060030/S075)Roche Molecular Systems, Inc.2019-05-09
Cobas HPV Test (P100020/S046)Roche Molecular Systems, Inc.2019-05-09
Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S046)Roche Molecular Systems, Inc.2019-05-09
Cobas HBV Test (P150014/S025)Roche Molecular Systems, Inc.2019-05-09
Cobas HCV Test (P150015/S027)Roche Molecular Systems, Inc.2019-05-09
COBAS TaqMan HBV Test for use on the High Pure System and COBAS AMpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S075)Roche Molecular Systems, Inc.2019-05-08
COBAS TaqMan HCV Test, v2.0 for use on the High Pure System (P060030/S074)Roche Molecular Systems, Inc.2019-05-08
COBAS HCV TEST (P150015/S026)Roche Molecular Systems, Inc.2019-05-08
COBAS HPV TEST (P100020/S045)Roche Molecular Systems, Inc.2019-05-08
cobas CMV (P160041/S017)Roche Molecular Systems, Inc.2019-05-03
cobas HBV (P150014/S024)Roche Molecular Systems, Inc.2019-05-03
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Every clearance here is in the API, with alerts when new ones post.