Device Classification Name |
test, qualitative, for hla, non-diagnostic
|
510(k) Number |
BK050062 |
Tradename |
BD HLA-B27 kit
|
Device Name |
Test, Qualitative, for HLA, Non-Diagnostic |
Original Applicant |
BD Biosciences |
2350 qume drive |
san jose,
CA
95131
1807
|
|
Classification Product Code |
|
Date Received | 09/27/2005 |
Decision Date | 10/27/2005 |
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 |
Yes
|
|
|