Device Classification Name |
Lipoprotein, Low-Density, Antigen, Antiserum, Control
More FDA Info for this Device |
510(K) Number |
K013128 |
Device Name |
Lipoprotein, Low-Density, Antigen, Antiserum, Control |
Applicant |
DADE BEHRING, INC.
GLASGOW SITE
P.O. BOX 6101
NEWARK, DE 19714-6101 US
Other 510(k) Applications for this Company
|
Contact |
REBECCA S AYASH
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 |
09/19/2001 |
Decision Date |
01/18/2002 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
IM - Immunology |
Review Advisory Committee |
CH - Clinical Chemistry |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|