Device Classification Name |
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
|
510(k) Number |
K863075 |
Device Name |
TRIGLYCERIDES-E |
Applicant |
J. D. ASSOC. |
163 MONTCLAIR AVE. |
MONTCLAIR,
NJ
07042
|
|
Applicant Contact |
DI PIETRO |
Correspondent |
J. D. ASSOC. |
163 MONTCLAIR AVE. |
MONTCLAIR,
NJ
07042
|
|
Correspondent Contact |
DI PIETRO |
Regulation Number | 862.1705
|
Classification Product Code |
|
Date Received | 08/12/1986 |
Decision Date | 09/26/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|