Device Classification Name |
dna-reagents, neisseria
|
510(k) Number |
K163184 |
Device Name |
cobas® CT/NG v2.0 Test |
Applicant |
Roche Molecular Systems, Inc. |
4300 Hacienda Drive |
Pleasanton,
CA
94588
|
|
Applicant Contact |
David W. Gates |
Correspondent |
Roche Molecular Systems, Inc. |
4300 Hacienda Drive |
Pleasanton,
CA
94588
|
|
Correspondent Contact |
David W. Gates |
Regulation Number | 866.3390
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/14/2016 |
Decision Date | 02/09/2017 |
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
|
|
|