Device Classification Name |
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
|
510(k) Number |
K803091 |
Device Name |
TRIGLYCERIDES (UV)-2 REAGENTS |
Applicant |
REAGENTS APPLICATIONS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
REAGENTS APPLICATIONS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1705
|
Classification Product Code |
|
Date Received | 12/08/1980 |
Decision Date | 01/09/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|