Device Classification Name |
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
|
510(k) Number |
K852010 |
Device Name |
TGL REAGENT |
Applicant |
ALPKEM CORP. |
BOX 1260 |
CLACKAMAS,
OR
97015
|
|
Applicant Contact |
YOSIP F WARDA |
Correspondent |
ALPKEM CORP. |
BOX 1260 |
CLACKAMAS,
OR
97015
|
|
Correspondent Contact |
YOSIP F WARDA |
Regulation Number | 862.1705
|
Classification Product Code |
|
Date Received | 05/07/1985 |
Decision Date | 05/30/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|