Device Classification Name |
test, qualitative and quantitative factor deficiency
|
510(k) Number |
K200033 |
Device Name |
HemosIL von Willebrand Factor Antigen |
Applicant |
Instrumentation Laboratory Co. |
180 Hartwell Road |
Bedford,
MA
01730
|
|
Applicant Contact |
Nikita Malladi |
Correspondent |
Instrumentation Laboratory Co. |
180 Hartwell Road |
Bedford,
MA
01730
|
|
Correspondent Contact |
Nikita Malladi |
Regulation Number | 864.7290
|
Classification Product Code |
|
Date Received | 01/07/2020 |
Decision Date | 08/19/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|