Device Classification Name |
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
|
510(k) Number |
K854182 |
Device Name |
IN-VITRO TEST DETERMINATION OF TRIALYCERIDE |
Applicant |
CLINICAL DATA, INC. |
1172 COMMONWEALTH AVE. |
BOSTON,
MA
02134
|
|
Applicant Contact |
ISRAEL M STEIN |
Correspondent |
CLINICAL DATA, INC. |
1172 COMMONWEALTH AVE. |
BOSTON,
MA
02134
|
|
Correspondent Contact |
ISRAEL M STEIN |
Regulation Number | 862.1705
|
Classification Product Code |
|
Date Received | 10/15/1985 |
Decision Date | 11/25/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|