The following data is part of a premarket notification filed by Roche Molecular Systems, Inc. with the FDA for Cobas Bkv, Cobas Ebv/bkv Control Kit, Cobas Buffer Negative Control Kit.
| Device ID | K202215 |
| 510k Number | K202215 |
| Device Name: | Cobas BKV, Cobas EBV/BKV Control Kit, Cobas Buffer Negative Control Kit |
| Classification | Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (bk) Dna |
| 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 | QMI |
| CFR Regulation Number | 866.3183 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-06 |
| Decision Date | 2020-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00875197006278 | K202215 | 000 |