Device Classification Name |
Dna-Reagents, Neisseria
|
510(k) Number |
K132270 |
Device Name |
COBAS CT/NG V2.0 TEST |
Applicant |
ROCHE MOLECULAR SYSTEMS, INC. |
4300 HACIENDA DRIVE |
PLEASANTON,
CA
94588 -2722
|
|
Applicant Contact |
WILK VON GUSTEDT |
Correspondent |
ROCHE MOLECULAR SYSTEMS, INC. |
4300 HACIENDA DRIVE |
PLEASANTON,
CA
94588 -2722
|
|
Correspondent Contact |
WILK VON GUSTEDT |
Regulation Number | 866.3390
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/22/2013 |
Decision Date | 12/02/2013 |
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
|
|
|