Device Classification Name |
test, equipment, automated bloodborne pathogen
|
510(k) Number |
BK130006 |
Tradename |
ORTHO VERSEIA® Integrated Processor (VIP)
|
Device Name |
Test, Equipment, Automated Bloodborne Pathogen |
Original Applicant |
Ortho-Clinical Diagnostics, Inc. |
1001 u.s. highway 202 |
raritan,
NJ
08869
0606
|
|
Classification Product Code |
|
Date Received | 02/25/2013 |
Decision Date | 05/23/2013 |
Decision |
substantially equivalent (SE) |
Review Advisory Committee |
Immunology
|
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 |
Yes
|
|
|