Device Classification Name |
test, time, prothrombin
|
510(k) Number |
K062925 |
Device Name |
COAGUCHEK XS SYSTEM |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46256
|
|
Applicant Contact |
THERESA BUSH |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46256
|
|
Correspondent Contact |
THERESA BUSH |
Regulation Number | 864.7750
|
Classification Product Code |
|
Date Received | 09/28/2006 |
Decision Date | 01/29/2007 |
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
|
Recalls |
CDRH Recalls
|
|
|