Device Classification Name |
Lipoprotein, Low-Density, Antigen, Antiserum, Control
More FDA Info for this Device |
510(K) Number |
K001933 |
Device Name |
Lipoprotein, Low-Density, Antigen, Antiserum, Control |
Applicant |
WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND, VA 23237 US
Other 510(k) Applications for this Company
|
Contact |
TONYA MALLORY
Other 510(k) Applications for this Contact |
Regulation Number |
866.5600
More FDA Info for this Regulation Number |
Classification Product Code |
DFC
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
06/26/2000 |
Decision Date |
07/24/2000 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
IM - Immunology |
Review Advisory Committee |
IM - Immunology |
Statement / Summary / Purged Status |
Statement |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|