Device Classification Name |
Respiratory Virus Panel Nucleic Acid Assay System
|
510(k) Number |
K200065 |
FOIA Releasable 510(k) |
K200065
|
Device Name |
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System |
Applicant |
Roche Molecular Systems, Inc. |
4300 Hacienda Drive |
Pleasanton,
CA
94588 -2722
|
|
Applicant Contact |
Kaitlyn Hameister |
Correspondent |
Roche Molecular Systems, Inc. |
4300 Hacienda Drive |
Pleasanton,
CA
94588 -2722
|
|
Correspondent Contact |
Kaitlyn Hameister |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/13/2020 |
Decision Date | 02/10/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|