Device Classification Name |
Lipoprotein, Low-Density, Antigen, Antiserum, Control
More FDA Info for this Device |
510(K) Number |
K180074 |
Device Name |
Lipoprotein, Low-Density, Antigen, Antiserum, Control |
Applicant |
Diazyme Laboratories, Inc.
12889 Gregg Court
Poway, CA 92130 US
Other 510(k) Applications for this Company
|
Contact |
Abhijit Datta
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 |
01/10/2018 |
Decision Date |
03/22/2018 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
IM - Immunology |
Review Advisory Committee |
CH - Clinical Chemistry |
Statement / Summary / Purged Status |
Statement |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|