Device Classification Name |
lipase hydrolysis/glycerol kinase enzyme, triglycerides
|
510(k) Number |
K871122 |
Device Name |
TRIGLYCERIDES DETERMINATION |
Applicant |
BIOCHEMICAL TRADE, INC. |
P.O. BOX 520575 |
MIAMI,
FL
33152
|
|
Applicant Contact |
ALEJO V ROY |
Correspondent |
BIOCHEMICAL TRADE, INC. |
P.O. BOX 520575 |
MIAMI,
FL
33152
|
|
Correspondent Contact |
ALEJO V ROY |
Regulation Number | 862.1705
|
Classification Product Code |
|
Date Received | 03/20/1987 |
Decision Date | 04/07/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|