FDA 510(k) K240867, cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems, by Roche Molecular Systems, Inc.
FDA 510(k) K240867, cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems, by Roche Molecular Systems, Inc.
| 510(k) Number | K240867 |
| Device Classification Name | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test |
| Device Name | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems |
| Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Dr. Pleasanton, CA 94028 |
| Regulation Number | 866.3981 |
| Classification Product Code | QQX |
| Date Received | 03/29/2024 |
| Decision Date | 02/11/2025 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Microbiology |
| 510k Review Panel | Microbiology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 7563 |
| Redacted Pages | 4868 |
| Unredacted Pages | 2695 |
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