Device Classification Name |
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
More FDA Info for this Device |
510(K) Number |
K180202 |
Device Name |
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
Applicant |
Immuno Concepts, NA, Ltd.
9825 Goethe Rd., Suite 350
Sacramento, CA 95827 US
Other 510(k) Applications for this Company
|
Contact |
Eric S Hoy
Other 510(k) Applications for this Contact |
Regulation Number |
866.5660
More FDA Info for this Regulation Number |
Classification Product Code |
DBL
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
01/24/2018 |
Decision Date |
10/19/2018 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
IM - Immunology |
Review Advisory Committee |
IM - Immunology |
Statement / Summary / Purged Status |
Statement |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|