Device Classification Name |
container, empty, for collection & processing of blood & blood components
|
510(k) Number |
BK040020 |
Tradename |
Haemonetics LN994CF-BA Extended Storage Platelet and Plasma Apheresis Set with Leukocyte Reduction Filter, and 4 mL Sampling System.
|
Device Name |
Container, Empty, For the Collection '& Processing of Blood/Blood Components |
Original Applicant |
Haemonetics Corporation |
400 wood road |
braintree,
MA
02184
9114
|
|
Regulation Number | 864.9100
|
Classification Product Code |
|
Date Received | 03/05/2004 |
Decision Date | 03/29/2004 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Hematology
|
Review Advisory Committee |
Hematology
|
Type |
510(k) Special
|
Total Product Life Cycle (TPLC) |
TPLC Device Report
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
Combination Product |
No
|
In Vitro Product |
No
|
|
|