The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Sars-cov-2 Qualitative For Use On The Cobas 6800/8800 Systems.
| Device ID | K213804 |
| 510k Number | K213804 |
| Device Name: | Cobas SARS-CoV-2 Qualitative For Use On The Cobas 6800/8800 Systems |
| Classification | Respiratory Specimen Nucleic Acid Sars-cov-2 Test |
| Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| Contact | Rita Hoady |
| Correspondent | Rita Hoady Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| Product Code | QQX |
| CFR Regulation Number | 866.3981 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-06 |
| Decision Date | 2022-10-22 |