Device Classification Name |
enzymatic esterase--oxidase, cholesterol
|
510(k) Number |
K132031 |
Device Name |
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL |
Applicant |
AXIS-SHIELD POC AS |
P.O. BOX 6863 |
RODELOKKA |
OSLO,
NO
N-0504
|
|
Applicant Contact |
KARI SKINNEMOEN |
Correspondent |
AXIS-SHIELD POC AS |
P.O. BOX 6863 |
RODELOKKA |
OSLO,
NO
N-0504
|
|
Correspondent Contact |
KARI SKINNEMOEN |
Regulation Number | 862.1175
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/18/2013 |
Decision Date | 03/21/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|