Device Classification Name |
Test, Time, Prothrombin
|
510(k) Number |
K092940 |
Device Name |
COAGUCHEK XS PLUS PST SYSTEM |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
JENNIFER TRIBBETT |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
JENNIFER TRIBBETT |
Regulation Number | 864.7750
|
Classification Product Code |
|
Date Received | 09/24/2009 |
Decision Date | 03/05/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|