The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Bkv.
| Device ID | K203220 |
| 510k Number | K203220 |
| Device Name: | Cobas BKV |
| Classification | Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna |
| Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| Contact | Raji Grewal |
| Correspondent | Raji Grewal Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 -2722 |
| Product Code | QLX |
| CFR Regulation Number | 866.3183 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-02 |
| Decision Date | 2021-01-29 |