Device Classification Name |
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
|
510(k) Number |
K102993 |
Device Name |
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL |
Applicant |
SEPPIM S.A.S. |
21720 23RD DR SE |
SUITE 150 |
BOTHELL,
WA
98021
|
|
Applicant Contact |
DEBRA K HUTSON |
Correspondent |
SEPPIM S.A.S. |
21720 23RD DR SE |
SUITE 150 |
BOTHELL,
WA
98021
|
|
Correspondent Contact |
DEBRA K HUTSON |
Regulation Number | 862.1705
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/08/2010 |
Decision Date | 05/19/2011 |
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
|
|
|