Device Classification Name |
blood establishment computer software and accessories
|
510(k) Number |
BK030073 |
Tradename |
Configurable Manual Batch Entry
|
Device Name |
Blood Establishment Computer Software and Accessories |
Original Applicant |
Rubin & Poor, Inc. |
155 maplewood avenue #5 |
maplewood,
NJ
07040
|
|
Regulation Number | 864.9165
|
Classification Product Code |
|
Date Received | 11/06/2003 |
Decision Date | 01/14/2004 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Hematology
|
Review Advisory Committee |
Hematology
|
Type |
510(k) Abbreviated
|
Total Product Life Cycle (TPLC) |
TPLC Device Report
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
Combination Product |
No
|
In Vitro Product |
No
|