Device Classification Name |
lipase hydrolysis/glycerol kinase enzyme, triglycerides
|
510(k) Number |
K893917 |
Device Name |
EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421 |
Applicant |
EM DIAGNOSTIC SYSTEMS, INC. |
480 DEMOCRAT RD. |
GIBBSTOWN,
NJ
08027
|
|
Applicant Contact |
ANNA G BENTLEY |
Correspondent |
EM DIAGNOSTIC SYSTEMS, INC. |
480 DEMOCRAT RD. |
GIBBSTOWN,
NJ
08027
|
|
Correspondent Contact |
ANNA G BENTLEY |
Regulation Number | 862.1705
|
Classification Product Code |
|
Date Received | 05/30/1989 |
Decision Date | 08/28/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|