Device Classification Name |
fibrinogen and fibrin split products, antigen, antiserum, control
|
510(k) Number |
K090264 |
Device Name |
HEMOSIL D-DIMER HS 500, CONTROLS |
Applicant |
INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD |
BEDFORD,
MA
01730
|
|
Applicant Contact |
CAROL MARBLE |
Correspondent |
INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD |
BEDFORD,
MA
01730
|
|
Correspondent Contact |
CAROL MARBLE |
Regulation Number | 864.7320
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/03/2009 |
Decision Date | 02/05/2010 |
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
|
|
|