Device Classification Name |
lipase hydrolysis/glycerol kinase enzyme, triglycerides
|
510(k) Number |
K860730 |
Device Name |
ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL) |
Applicant |
TRACE SCIENTIFIC LTD. |
10 TREFOREST DR. |
CLAYTON, VIC 3168,
AU
|
|
Applicant Contact |
W. C RIDDLE |
Correspondent |
TRACE SCIENTIFIC LTD. |
10 TREFOREST DR. |
CLAYTON, VIC 3168,
AU
|
|
Correspondent Contact |
W. C RIDDLE |
Regulation Number | 862.1705
|
Classification Product Code |
|
Date Received | 02/26/1986 |
Decision Date | 04/07/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|