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Roche Molecular Systems, Inc.

644 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Cobas HBV Test (P150014/S014)Roche Molecular Systems, Inc.2018-03-26
Cobas HCV Test (P150015/S013)Roche Molecular Systems, Inc.2018-03-26
Cobas CMV (P160041/S006)Roche Molecular Systems, Inc.2018-03-16
Cobas HCV Test (P150015/S012)Roche Molecular Systems, Inc.2018-02-20
Cobas HBV Test (P150014/S013)Roche Molecular Systems, Inc.2018-02-20
Cobas CMV Test (P160041/S005)Roche Molecular Systems, Inc.2018-02-20
Cobas 4800 Wash and Lysis Reagents (P100020/S028)Roche Molecular Systems, Inc.2017-12-26
Cobas TaqMan HBV Test v2.0 (P050028/S060)Roche Molecular Systems, Inc.2017-12-20
Cobas TaqMan HCV Test, v2.0 (P060030/S061)Roche Molecular Systems, Inc.2017-12-20
Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S033)Roche Molecular Systems, Inc.2017-12-20
Cobas HCV (P150015/S011)Roche Molecular Systems, Inc.2017-12-11
Cobas CMV (P160041/S004)Roche Molecular Systems, Inc.2017-12-11
Cobas HBV (P150014/S012)Roche Molecular Systems, Inc.2017-12-11
Cobas 4800 BRAF V600 Mutation Test (P110020/S023)Roche Molecular Systems, Inc.2017-11-13
Cobas HCV (P150015/S010)Roche Molecular Systems, Inc.2017-11-13
Cobas HPV Test (P100020/S027)Roche Molecular Systems, Inc.2017-11-13
Cobas HBV (P150014/S011)Roche Molecular Systems, Inc.2017-11-13
Roche Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 (P050028/S059)Roche Molecular Systems, Inc.2017-11-13
Cobas CMV (P160041/S003)Roche Molecular Systems, Inc.2017-11-13
Cobas KRAS Mutation Test (P140023/S012)Roche Molecular Systems, Inc.2017-11-13
cobas HCV Test (P150015/S009)Roche Molecular Systems, Inc.2017-10-26
cobas HBV Test (P150014/S010)Roche Molecular Systems, Inc.2017-10-26
Roche cobas HPV Test (P100020/S026)Roche Molecular Systems, Inc.2017-10-23
Roche cobas KRAS Mutation Test /Roche cobas DNA Sample Preparation Kit (P140023/S011)Roche Molecular Systems, Inc.2017-10-16
COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test (P110037/S032)Roche Molecular Systems, Inc.2017-10-13
Roche cobas DNA Sample Preparation Kit / Roche cobas 4800 BRAF V600 Mutation Test (P110020/S022)Roche Molecular Systems, Inc.2017-10-13
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S060)Roche Molecular Systems, Inc.2017-10-13
COBAS TaqMan HBV Test / High Pure System Viral Nucleic Acid Kit (P050028/S058)Roche Molecular Systems, Inc.2017-10-13
cobas CMV test for use on the cobas 6800/8800 System (P160041/S002)Roche Molecular Systems, Inc.2017-10-13
cobas HBV Test (P150014/S009)Roche Molecular Systems, Inc.2017-10-13
Cobas HCV Test (P150015/S008)Roche Molecular Systems, Inc.2017-10-13
COBAS AmpliPrep/COBAS TaqMan HCV Test, v 2.0 (P060030/S059)Roche Molecular Systems, Inc.2017-09-01
cobas KRAS Mutation Test (P140023/S010)Roche Molecular Systems, Inc.2017-08-15
cobas HPV Test (P100020/S024)Roche Molecular Systems, Inc.2017-08-15
cobas 4800 BRAF V600 Mutation Test (P110020/S021)Roche Molecular Systems, Inc.2017-08-15
COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037/S031)Roche Molecular Systems, Inc.2017-08-11
COBAS TAQMAN HBV TEST (P050028/S057)Roche Molecular Systems, Inc.2017-08-11
COBAS HPV TEST (P100020/S023)Roche Molecular Systems, Inc.2017-08-11
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S020)Roche Molecular Systems, Inc.2017-08-11
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S058)Roche Molecular Systems, Inc.2017-08-11
cobas HBV Test (P150014/S008)Roche Molecular Systems, Inc.2017-08-09
cobas KRAS Mutation Test (P140023/S009)Roche Molecular Systems, Inc.2017-08-09
COBAS TaqMan HCV Test, v2.0, for Use with the High Pure System/COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S057)Roche Molecular Systems, Inc.2017-08-09
cobas HPV Test (P100020/S022)Roche Molecular Systems, Inc.2017-08-09
COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S030)Roche Molecular Systems, Inc.2017-08-09
cobas HCV Test (P150015/S007)Roche Molecular Systems, Inc.2017-08-09
COBAS TaqMan HBV Test for Use with the High Pure System/COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S056)Roche Molecular Systems, Inc.2017-08-09
cobas BRAF V600 Mutation Test (P110020/S019)Roche Molecular Systems, Inc.2017-08-09
cobas CMV Test (P160041/S001)Roche Molecular Systems, Inc.2017-08-09
Roche cobas HBV (P150014/S007)Roche Molecular Systems, Inc.2017-06-07
Roche cobas HCV (P150015/S006)Roche Molecular Systems, Inc.2017-06-07
COBAS CMV (P160041)Roche Molecular Systems, Inc.2017-06-01
COBAS TaqMan HCV Test v2.0, For Use With High Pure System (P060030/S056)Roche Molecular Systems, Inc.2017-05-10
COBAS TaqMan HBV Test, For Use With High Pure System (P050028/S055)Roche Molecular Systems, Inc.2017-05-10
COBAS HCV (P150015/S005)Roche Molecular Systems, Inc.2016-12-19
COBAS HBV (P150014/S006)Roche Molecular Systems, Inc.2016-12-19
Roche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST (P110020/S016)Roche Molecular Systems, Inc.2016-11-07
COBAS HBV TEST (P150014/S004)Roche Molecular Systems, Inc.2016-10-31
COBAS HCV TEST (P150015/S004)Roche Molecular Systems, Inc.2016-10-31
COBAS HBV TEST (P150014/S005)Roche Molecular Systems, Inc.2016-10-31
COBAS KRAS MUTATION TEST (P140023/S008)Roche Molecular Systems, Inc.2016-10-19
Cobas EGFR MUTATION TEST v2 (P150047/S002)Roche Molecular Systems, Inc.2016-10-19
COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S055)Roche Molecular Systems, Inc.2016-10-18
COBAS TaqMan HBV Test, High Pure System Viral Nucleic Acid Kit (P050028/S054)Roche Molecular Systems, Inc.2016-10-18
COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test (P110037/S029)Roche Molecular Systems, Inc.2016-10-18
COBAS HPV TEST (P100020/S021)Roche Molecular Systems, Inc.2016-10-18
cobas EGFR MUTATION TEST v2 (P150044)Roche Molecular Systems, Inc.2016-09-28
COBAS KRAS MUTATION TEST (P140023/S004)Roche Molecular Systems, Inc.2016-09-24
COBAS KRAS MUTATION TEST (P140023/S007)Roche Molecular Systems, Inc.2016-09-20
COBAS EGFR MUTATION TEST (P150047/S001)Roche Molecular Systems, Inc.2016-09-20
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S018)Roche Molecular Systems, Inc.2016-09-20
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S054)Roche Molecular Systems, Inc.2016-09-13
COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037/S028)Roche Molecular Systems, Inc.2016-08-18
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S053)Roche Molecular Systems, Inc.2016-08-18
COBAS AmpliPrep/Cobas TAQMAN HBV TEST and Cobas TaqMan HBV Test for user with The High Pure System (P050028/S053)Roche Molecular Systems, Inc.2016-08-18
COBAS HPV TEST (P100020/S020)Roche Molecular Systems, Inc.2016-08-05
COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037/S027)Roche Molecular Systems, Inc.2016-08-04
COBAS HCV TEST (P150015/S003)Roche Molecular Systems, Inc.2016-08-04
COBAS HBV TEST (P150014/S003)Roche Molecular Systems, Inc.2016-08-04
COBAS AMPLICOR HCV (P000012/S056)Roche Molecular Systems, Inc.2016-08-04
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S017)Roche Molecular Systems, Inc.2016-08-04
COBAS KRAS MUTATION TEST (P140023/S006)Roche Molecular Systems, Inc.2016-08-04
COBAS TAQMAN HCV (P060030/S052)Roche Molecular Systems, Inc.2016-08-04
COBAS TAQMAN HBV TEST (P050028/S052)Roche Molecular Systems, Inc.2016-08-04
COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS (P100020/S017)Roche Molecular Systems, Inc.2016-07-07
cobas EGFR MUTATION TEST v2 (P150047)Roche Molecular Systems, Inc.2016-06-01
COBAS AMPLIPREP/COBAS TAQMAN CYTOMEGALOVIRUS TEST (P110037/S023)Roche Molecular Systems, Inc.2016-05-20
COBAS KRAS MUTATION TEST (P140023/S005)Roche Molecular Systems, Inc.2016-05-13
COBAS HPV TEST (P100020/S019)Roche Molecular Systems, Inc.2016-05-13
COBAS TAQMAN HBV TEST (P050028/S051)Roche Molecular Systems, Inc.2016-05-13
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S051)Roche Molecular Systems, Inc.2016-05-13
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S015)Roche Molecular Systems, Inc.2016-05-13
COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0 (P000012/S055)Roche Molecular Systems, Inc.2016-05-13
COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037/S026)Roche Molecular Systems, Inc.2016-05-13
COBAS TAQMAN HBV TEST (P050028/S050)Roche Molecular Systems, Inc.2016-04-29
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S050)Roche Molecular Systems, Inc.2016-04-29
COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST) (P110037/S025)Roche Molecular Systems, Inc.2016-04-29
COBAS HPV TEST (P100020/S018)Roche Molecular Systems, Inc.2016-04-29
COBAS HBV TEST (P150014/S002)Roche Molecular Systems, Inc.2016-04-29
COBAS HCV TEST (P150015/S002)Roche Molecular Systems, Inc.2016-04-29
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