Device Classification Name |
test, qualitative, for hla, non-diagnostic
|
510(k) Number |
BK120024 |
Tradename |
LABType (R) SSO DNA Typing Tests for use with LABScanTM 3D
|
Device Name |
Test, Qualitative, for HLA, Non-Diagnostic |
Original Applicant |
One Lambda, Inc |
21001 kittridge st |
canoga park,
CA
91303
|
|
Classification Product Code |
|
Date Received | 05/08/2012 |
Decision Date | 12/20/2012 |
Decision |
substantially equivalent (SE) |
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 |
Yes
|
|
|