Device Classification Name |
Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
|
510(k) Number |
K202215 |
Device Name |
cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit |
Applicant |
Roche Molecular Systems, Inc. |
4300 Hacienda Drive |
Pleasanton,
CA
94588 -2722
|
|
Applicant Contact |
Rita Hoady |
Correspondent |
Roche Molecular Systems, Inc. |
4300 Hacienda Drive |
Pleasanton,
CA
94588 -2722
|
|
Correspondent Contact |
Rita Hoady |
Regulation Number | 866.3183
|
Classification Product Code |
|
Date Received | 08/06/2020 |
Decision Date | 09/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|