Device Classification Name |
test, time, prothrombin
|
510(k) Number |
K180693 |
Device Name |
CoaguChek XS Pro System |
Applicant |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Applicant Contact |
Angie Clements |
Correspondent |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Correspondent Contact |
Angie Clements |
Regulation Number | 864.7750
|
Classification Product Code |
|
Date Received | 03/16/2018 |
Decision Date | 04/19/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|