Device Classification Name |
supplies, blood-bank
|
510(k) Number |
BK000037 |
Tradename |
Harvest PRP Separation System
|
Device Name |
Supplies, Blood-Bank |
Original Applicant |
Harvest Technologies Corp |
40 grissom road |
plymouth,
MA
02360
|
|
Regulation Number | 864.9050
|
Classification Product Code |
|
Date Received | 08/11/2000 |
Decision Date | 02/05/2001 |
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
|
|
|