Roche Diagnostics Operations, Inc.
40 FDA 510(k) clearances · PMA applicant
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| Record | Firm | Date |
|---|---|---|
| Elecsys HBeAg (P130015/S022) | Roche Diagnostics Operations, Inc. | 2025-05-22 |
| Elecsys HBeAg (P130015/S021) | Roche Diagnostics Operations, Inc. | 2024-10-03 |
| Elecsys HBeAg (P130015/S020) | Roche Diagnostics Operations, Inc. | 2024-08-29 |
| Elecsys HBeAg (P130015/S019) | Roche Diagnostics Operations, Inc. | 2024-02-08 |
| Elecsys HBeAg (P130015/S018) | Roche Diagnostics Operations, Inc. | 2023-10-31 |
| Elecsys HBeAg Test System (P130015/S017) | Roche Diagnostics Operations, Inc. | 2023-04-18 |
| Elecsys Anti-HCV II (P140021/S016) | Roche Diagnostics Operations, Inc. | 2019-04-24 |
| Elecsys HBeAg (P130015/S016) | Roche Diagnostics Operations, Inc. | 2018-11-06 |
| Elecsys ANti-HCV II (100/200 tests) (P140021/S015) | Roche Diagnostics Operations, Inc. | 2018-11-06 |
| Elecsys Anti-HCV II (P140021/S014) | Roche Diagnostics Operations, Inc. | 2018-06-13 |
| Elecsys HBcAg (P130015/S015) | Roche Diagnostics Operations, Inc. | 2018-06-13 |
| Elecsys Anti-HCV II (P140021/S013) | Roche Diagnostics Operations, Inc. | 2018-04-20 |
| Elecsys HBeAg and PreciControl HBeAg (P130015/S013) | Roche Diagnostics Operations, Inc. | 2018-03-02 |
| Elecsys HBeAg (P130015/S014) | Roche Diagnostics Operations, Inc. | 2017-12-20 |
| Elecsys Anti-HCV II (P140021/S012) | Roche Diagnostics Operations, Inc. | 2017-12-20 |
| Elecsys Anti-HCV II, PreciControl Anti-HCV (P140021/S010) | Roche Diagnostics Operations, Inc. | 2017-11-03 |
| Elecsys Anit-HCV II (P140021/S011) | Roche Diagnostics Operations, Inc. | 2017-08-31 |
| Elecsys HBeAg (P130015/S012) | Roche Diagnostics Operations, Inc. | 2017-08-31 |
| Elecsys HBeAg and PreciControl HBeAg (P130015/S011) | Roche Diagnostics Operations, Inc. | 2017-08-16 |
| Elecsys Anti-HCV II Test System (P140021/S008) | Roche Diagnostics Operations, Inc. | 2017-08-10 |
| Elecsys Anti-HCV II (100/200 tests) Immunoassay (P140021/S009) | Roche Diagnostics Operations, Inc. | 2017-06-23 |
| Elecsys HBeAg Immunoassay (P130015/S010) | Roche Diagnostics Operations, Inc. | 2017-06-23 |
| ELECSYS HBEAG AND PRECICONTROL HBEAG (P130015/S009) | Roche Diagnostics Operations, Inc. | 2017-01-13 |
| ELECSYS HBEAG (P130015/S008) | Roche Diagnostics Operations, Inc. | 2016-11-22 |
| ELECSYS ANTI-HCV II IMMUNOASSAY. (P140021/S007) | Roche Diagnostics Operations, Inc. | 2016-11-10 |
| ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG (P130015/S007) | Roche Diagnostics Operations, Inc. | 2016-10-24 |
| ELECSYS ANTI-HCV II IMMUNOASSAY (P140021/S003) | Roche Diagnostics Operations, Inc. | 2016-08-08 |
| ELECSYS HBEAG IMMUNOASSAY (P130015/S005) | Roche Diagnostics Operations, Inc. | 2016-08-08 |
| ELECSYS ANTI-HCV II TEST SYSTEM (P140021/S005) | Roche Diagnostics Operations, Inc. | 2016-07-25 |
| ELECSYS ANTI-HCV II IMMUNOASSAY (P140021/S002) | Roche Diagnostics Operations, Inc. | 2016-04-12 |
| ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG (P130015/S006) | Roche Diagnostics Operations, Inc. | 2016-03-16 |
| ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV (P140021/S006) | Roche Diagnostics Operations, Inc. | 2016-03-16 |
| ELECSYS ANTI-HCV II TEST SYSTEM (P140021/S004) | Roche Diagnostics Operations, Inc. | 2016-02-24 |
| ELECSYS ANTI-HCV II (P140021/S001) | Roche Diagnostics Operations, Inc. | 2015-11-24 |
| ELECSYS HBEAG (P130015/S004) | Roche Diagnostics Operations, Inc. | 2015-11-24 |
| ELECSYS HBEAG IMMUNOASSAY/ELECSYS PRECICONTROL HBEAG (P130015/S003) | Roche Diagnostics Operations, Inc. | 2015-07-28 |
| ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV (P140021) | Roche Diagnostics Operations, Inc. | 2015-06-11 |
| ELECSYS HBEAG ON MODULAR ANALYTICS E170 (P130015/S002) | Roche Diagnostics Operations, Inc. | 2014-11-26 |
| ELECSYS HBEAG IMMUNOASSAY AND ELECSYS PRECICONTROL HBEAG (P130015/S001) | Roche Diagnostics Operations, Inc. | 2014-06-06 |
| ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG (P130015) | Roche Diagnostics Operations, Inc. | 2014-03-14 |
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Every clearance here is in the API, with alerts when new ones post.