Device Classification Name |
lipase hydrolysis/glycerol kinase enzyme, triglycerides
|
510(k) Number |
K854783 |
Device Name |
TRIGLYCERIDE'S TEST (TRIGLI-CINET) |
Applicant |
SCLAVO, INC. |
5 MANSARD COURT |
WAYNE,
NJ
07470
|
|
Applicant Contact |
DEBRA HOFMEISTER |
Correspondent |
SCLAVO, INC. |
5 MANSARD COURT |
WAYNE,
NJ
07470
|
|
Correspondent Contact |
DEBRA HOFMEISTER |
Regulation Number | 862.1705
|
Classification Product Code |
|
Date Received | 11/29/1985 |
Decision Date | 01/22/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|