Device Classification Name |
test, qualitative and quantitative factor deficiency
|
510(k) Number |
K102164 |
Device Name |
HEMOSIL PROTEIN S ACTIVITY ASSAY |
Applicant |
INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD |
BEDFORD,
MA
01730
|
|
Applicant Contact |
Jacqueline Emery |
Correspondent |
INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD |
BEDFORD,
MA
01730
|
|
Correspondent Contact |
Jacqueline Emery |
Regulation Number | 864.7290
|
Classification Product Code |
|
Date Received | 08/02/2010 |
Decision Date | 03/17/2011 |
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
|
|
|