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 |