Device Classification Name |
software, blood virus applications
|
510(k) Number |
BK130020 |
Tradename |
ABBOTT PRISM Director
|
Device Name |
SOFTWARE, BLOOD VIRUS APPLICATION |
Original Applicant |
Abbott Laboratories |
dept 09va, bldg ap8-1 |
100 abbott park road |
abbott park,
IL
60064
3500
|
|
Classification Product Code |
|
Date Received | 04/16/2013 |
Decision Date | 05/14/2013 |
Decision |
substantially equivalent (SE) |
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
|
|
|