Device Classification Name |
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
|
510(k) Number |
K964346 |
Device Name |
PARAMAX TRIGLYCERID REAGENT |
Applicant |
DADE INTL., INC. |
9750 N.W. 25TH ST. |
MIAMI,
FL
33172
|
|
Applicant Contact |
MARIAN HARDING COCHRAN, ESQ. |
Correspondent |
DADE INTL., INC. |
9750 N.W. 25TH ST. |
MIAMI,
FL
33172
|
|
Correspondent Contact |
MARIAN HARDING COCHRAN, ESQ. |
Regulation Number | 862.1705
|
Classification Product Code |
|
Date Received | 10/31/1996 |
Decision Date | 03/28/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|