Device Classification Name |
Fibrin Split Products
|
510(k) Number |
K030740 |
Device Name |
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
SHERRI L COENEN |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
SHERRI L COENEN |
Regulation Number | 864.7320
|
Classification Product Code |
|
Date Received | 03/10/2003 |
Decision Date | 04/01/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|