Device Classification Name |
fibrin split products
|
510(k) Number |
K072288 |
Device Name |
PATHFAST D-DIMER |
Applicant |
MITSUBISHI KAGAKU IATRON |
701 FIFTH AVENUE |
FLOOR 42 |
SEATTLE,
WA
98104
|
|
Applicant Contact |
HELEN LANDICHO |
Correspondent |
MITSUBISHI KAGAKU IATRON |
701 FIFTH AVENUE |
FLOOR 42 |
SEATTLE,
WA
98104
|
|
Correspondent Contact |
HELEN LANDICHO |
Regulation Number | 864.7320
|
Classification Product Code |
|
Date Received | 08/16/2007 |
Decision Date | 05/06/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|