Device Classification Name |
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
|
510(k) Number |
K790773 |
Device Name |
ENZYMATIC TRIGLYCERIDES-S.V.R. |
Applicant |
CALBIOCHEM-BEHRING CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
CALBIOCHEM-BEHRING CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1705
|
Classification Product Code |
|
Date Received | 04/20/1979 |
Decision Date | 06/15/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|