Device Classification Name |
lipase hydrolysis/glycerol kinase enzyme, triglycerides
|
510(k) Number |
K861670 |
Device Name |
TRIGLYCERIDE (TRINDER) PROCEDURE |
Applicant |
DATA MEDICAL ASSOCIATES, INC. |
845 AVENUE G EAST |
ARLINGTON,
TX
76011
|
|
Applicant Contact |
JERRY A GRAHAM |
Correspondent |
DATA MEDICAL ASSOCIATES, INC. |
845 AVENUE G EAST |
ARLINGTON,
TX
76011
|
|
Correspondent Contact |
JERRY A GRAHAM |
Regulation Number | 862.1705
|
Classification Product Code |
|
Date Received | 04/30/1986 |
Decision Date | 07/01/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|