Device Classification Name |
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
More FDA Info for this Device |
510(K) Number |
K172195 |
Device Name |
Immunoelectrophoretic, Immunoglobulins, (G, A, M) |
Applicant |
Sebia
1705 Corporate Drive, Suite 400
Norcross, GA 30093 US
Other 510(k) Applications for this Company
|
Contact |
Karen Anderson
Other 510(k) Applications for this Contact |
Regulation Number |
866.5510
More FDA Info for this Regulation Number |
Classification Product Code |
CFF
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
07/21/2017 |
Decision Date |
01/11/2018 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
IM - Immunology |
Review Advisory Committee |
IM - Immunology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|