Device Classification Name |
set, transfer (blood/plasma)
|
510(k) Number |
BK040001 |
Tradename |
Haemonetics 4mL Sampling System
|
Device Name |
Set, Transfer (Blood/Plasma) |
Original Applicant |
Haemonetics Corporation |
400 wood road |
braintree,
MA
02184
9114
|
|
Regulation Number | 864.9875
|
Classification Product Code |
|
Date Received | 01/20/2004 |
Decision Date | 02/27/2004 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Hematology
|
Review Advisory Committee |
Hematology
|
Type |
510(k) Traditional
|
Total Product Life Cycle (TPLC) |
TPLC Device Report
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
Combination Product |
No
|
In Vitro Product |
No
|
|
|