Device Classification Name |
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
|
510(k) Number |
K922229 |
Device Name |
OLYMPUS TRIGLYCERIDE REAGENT |
Applicant |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Applicant Contact |
LAURA STORMS-TYLER |
Correspondent |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Correspondent Contact |
LAURA STORMS-TYLER |
Regulation Number | 862.1705
|
Classification Product Code |
|
Date Received | 05/12/1992 |
Decision Date | 07/02/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|