Roche Molecular Systems, Inc.
644 FDA 510(k) clearances · PMA applicant
◉ Watch Roche Molecular Systems, Inc.
| Record | Firm | Date |
|---|---|---|
| cobas® HPV (P190028/S022) | Roche Molecular Systems, Inc. | 2025-12-31 |
| cobsa® BRAF V600 Mutation Test (P110020/S043) | Roche Molecular Systems, Inc. | 2025-12-31 |
| cobas® KRAS Mutation Test (P140023/S031) | Roche Molecular Systems, Inc. | 2025-12-31 |
| cobas® HPV (P100020/S064) | Roche Molecular Systems, Inc. | 2025-12-31 |
| COBAS HPV TEST (P100020/S063) | Roche Molecular Systems, Inc. | 2025-12-15 |
| cobas® HBV (P150014/S056) | Roche Molecular Systems, Inc. | 2025-10-17 |
| cobas HPV (P190028/S021) | Roche Molecular Systems, Inc. | 2025-09-19 |
| cobas HBV (P150014/S058) | Roche Molecular Systems, Inc. | 2025-09-19 |
| cobas® HPV (P190028/S020) | Roche Molecular Systems, Inc. | 2025-08-07 |
| cobas® HBV (P150014/S057) | Roche Molecular Systems, Inc. | 2025-08-07 |
| cobas HPV TEST (P100020/S062) | Roche Molecular Systems, Inc. | 2025-03-27 |
| cobas HPV for use on the cobas 6800/8800 Systems (P190028/S019) | Roche Molecular Systems, Inc. | 2025-03-27 |
| COBAS CMV (P160041/S045) | Roche Molecular Systems, Inc. | 2024-10-10 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S064) | Roche Molecular Systems, Inc. | 2024-10-04 |
| cobas HBV (P150014/S052) | Roche Molecular Systems, Inc. | 2024-10-04 |
| cobas CMV (P160041/S043) | Roche Molecular Systems, Inc. | 2024-10-04 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S094) | Roche Molecular Systems, Inc. | 2024-10-04 |
| cobas HPV (P190028/S017) | Roche Molecular Systems, Inc. | 2024-10-04 |
| cobas CMV (P160041/S044) | Roche Molecular Systems, Inc. | 2024-10-02 |
| cobas HBV (P150014/S053) | Roche Molecular Systems, Inc. | 2024-10-02 |
| cobas® CMV (P160041/S046) | Roche Molecular Systems, Inc. | 2024-09-27 |
| cobas® HPV (P190028/S018) | Roche Molecular Systems, Inc. | 2024-09-27 |
| cobas® HBV (P150014/S055) | Roche Molecular Systems, Inc. | 2024-09-27 |
| cobas HPV (P190028/S016) | Roche Molecular Systems, Inc. | 2024-09-11 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S063) | Roche Molecular Systems, Inc. | 2024-09-11 |
| cobas CMV (P160041/S042) | Roche Molecular Systems, Inc. | 2024-09-11 |
| cobas HBV (P150014/S051) | Roche Molecular Systems, Inc. | 2024-09-11 |
| COBAS AmpliPrep/ COBAS TaqMan HBV Test, v 2.0 (P050028/S093) | Roche Molecular Systems, Inc. | 2024-09-11 |
| cobas HPV Test (P100020/S061) | Roche Molecular Systems, Inc. | 2024-08-14 |
| cobas HPV (P190028/S015) | Roche Molecular Systems, Inc. | 2024-07-01 |
| Roche cobas HBV (P150014/S050) | Roche Molecular Systems, Inc. | 2024-07-01 |
| cobas CMV (P160041/S041) | Roche Molecular Systems, Inc. | 2024-07-01 |
| cobas® HPV Test (P100020/S060) | Roche Molecular Systems, Inc. | 2024-06-14 |
| Roche cobas KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit (P140023/S030) | Roche Molecular Systems, Inc. | 2024-05-15 |
| cobas HPV Test (P100020/S055) | Roche Molecular Systems, Inc. | 2024-05-14 |
| cobas HPV (P190028/S009) | Roche Molecular Systems, Inc. | 2024-05-14 |
| Roche cobas 4800 BRAF V600 Mutation Test (P110020/S042) | Roche Molecular Systems, Inc. | 2024-04-11 |
| Roche cobas DNA Sample Preparation Kit (P140023/S029) | Roche Molecular Systems, Inc. | 2024-04-11 |
| cobas® HPV (P100020/S059) | Roche Molecular Systems, Inc. | 2024-02-23 |
| COBAS® AmpliPrep®, COBAS® TaqMan® HBV Test, v2.0 (P050028/S092) | Roche Molecular Systems, Inc. | 2024-02-23 |
| COBAS® AmpliPrep®, COBAS® TaqMan® CMV Test (P110037/S062) | Roche Molecular Systems, Inc. | 2024-02-23 |
| cobas® HBV (P150014/S049) | Roche Molecular Systems, Inc. | 2024-01-18 |
| Roche cobas KRAS Mutation Test (P140023/S028) | Roche Molecular Systems, Inc. | 2023-12-21 |
| Roche cobas BRAF V600 Mutation Test (P110020/S041) | Roche Molecular Systems, Inc. | 2023-12-21 |
| COBAS® AmpliPrep® / COBAS® TaqMan® HBV Test, v2.0 (P050028/S091) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas® KRAS Mutation Test (P140023/S027) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas® HPV (P190028/S014) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas® HPV (P100020/S058) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas® CMV (P160041/S040) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas® BRAF V600 Mutation Test (P110020/S040) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas® HBV (P150014/S047) | Roche Molecular Systems, Inc. | 2023-12-14 |
| COBAS® AmpliPrep® / COBAS® TaqMan® HBV Test, v2.0 (P050028/S089) | Roche Molecular Systems, Inc. | 2023-12-14 |
| COBAS® AmpliPrep® / COBAS® TaqMan® CMV Test (P110037/S060) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas HPV (P190028/S013) | Roche Molecular Systems, Inc. | 2023-12-14 |
| COBAS® AmpliPrep® / COBAS® TaqMan® CMV Test (P110037/S061) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas® HBV (P150014/S048) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas® CMV (P160041/S039) | Roche Molecular Systems, Inc. | 2023-12-14 |
| cobas® HPV (P190028/S007) | Roche Molecular Systems, Inc. | 2023-10-04 |
| cobas® HPV (P190028/S012) | Roche Molecular Systems, Inc. | 2023-08-23 |
| COBAS® AmpliPrep/COBAS® TaqMan® HBV Test (P050028/S088) | Roche Molecular Systems, Inc. | 2023-08-23 |
| cobas® CMV (P160041/S038) | Roche Molecular Systems, Inc. | 2023-08-23 |
| COBAS® AmpliPrep/COBAS® TaqMan® CMV Test (P110037/S059) | Roche Molecular Systems, Inc. | 2023-08-23 |
| cobas® HBV (P150014/S046) | Roche Molecular Systems, Inc. | 2023-08-23 |
| cobas® 4800 HPV Test (P100020/S057) | Roche Molecular Systems, Inc. | 2023-08-23 |
| cobas® 4800 BRAF V600 Mutation Test (P110020/S039) | Roche Molecular Systems, Inc. | 2023-08-23 |
| Roche cobas DNA Sample Preparation Kit, Roche cobas 4800 BRAF V600 Mutation Test (P110020/S038) | Roche Molecular Systems, Inc. | 2023-08-17 |
| cobas® HBV (P150014/S044) | Roche Molecular Systems, Inc. | 2023-08-17 |
| cobas® HPV (P190028/S010) | Roche Molecular Systems, Inc. | 2023-08-17 |
| cobas HPV Test, 240 Tests, cobas HPV Test, 960 Tests (P100020/S056) | Roche Molecular Systems, Inc. | 2023-08-17 |
| COBAS® AmpliPrep, COBAS® TaqMan® HBV Test, v2.0 (P050028/S087) | Roche Molecular Systems, Inc. | 2023-08-17 |
| cobas® CMV (P160041/S036) | Roche Molecular Systems, Inc. | 2023-08-17 |
| Roche cobas® KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit (P140023/S026) | Roche Molecular Systems, Inc. | 2023-08-17 |
| COBAS® AmpliPrep, COBAS® TaqMan® CMV Test (P110037/S058) | Roche Molecular Systems, Inc. | 2023-08-17 |
| cobas® HBV (P150014/S045) | Roche Molecular Systems, Inc. | 2023-08-16 |
| cobas® CMV (P160041/S037) | Roche Molecular Systems, Inc. | 2023-08-16 |
| cobas® HPV (P190028/S011) | Roche Molecular Systems, Inc. | 2023-08-16 |
| cobas® HPV (P190028/S008) | Roche Molecular Systems, Inc. | 2023-05-16 |
| cobas® HBV (P150014/S043) | Roche Molecular Systems, Inc. | 2023-02-23 |
| cobas CMV (P160041/S035) | Roche Molecular Systems, Inc. | 2022-12-14 |
| cobas® KRAS Mutation Test (P140023/S024) | Roche Molecular Systems, Inc. | 2022-11-29 |
| cobas® BRAF V600 Mutation Test (P110020/S036) | Roche Molecular Systems, Inc. | 2022-11-29 |
| cobas® HPV (P100020/S054) | Roche Molecular Systems, Inc. | 2022-11-14 |
| cobas® BRAF V600 Mutation Test (P110020/S037) | Roche Molecular Systems, Inc. | 2022-11-14 |
| cobas® KRAS Mutation Test (P140023/S025) | Roche Molecular Systems, Inc. | 2022-11-14 |
| COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test (P110037/S057) | Roche Molecular Systems, Inc. | 2022-11-14 |
| COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0 (P050028/S086) | Roche Molecular Systems, Inc. | 2022-11-14 |
| Roche Cobas HBV (P150014/S042) | Roche Molecular Systems, Inc. | 2022-01-19 |
| Cobas HPV (P190028/S006) | Roche Molecular Systems, Inc. | 2022-01-19 |
| Cobas CMV (P160041/S034) | Roche Molecular Systems, Inc. | 2022-01-19 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 (P060030/S086) | Roche Molecular Systems, Inc. | 2021-08-11 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S056) | Roche Molecular Systems, Inc. | 2021-08-11 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S085) | Roche Molecular Systems, Inc. | 2021-08-11 |
| cobas HPV (P190028/S005) | Roche Molecular Systems, Inc. | 2021-06-02 |
| cobas CMV (P160041/S033) | Roche Molecular Systems, Inc. | 2021-06-02 |
| cobas HCV (P150015/S043) | Roche Molecular Systems, Inc. | 2021-06-02 |
| cobas HBV (P150014/S041) | Roche Molecular Systems, Inc. | 2021-06-02 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 (P060030/S085) | Roche Molecular Systems, Inc. | 2021-03-09 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S055) | Roche Molecular Systems, Inc. | 2021-03-09 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, V2.0 (P050028/S084) | Roche Molecular Systems, Inc. | 2021-03-09 |
| cobas CMV (P160041/S032) | Roche Molecular Systems, Inc. | 2020-12-10 |
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Every clearance here is in the API, with alerts when new ones post.