Device Classification Name |
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
|
510(k) Number |
K896231 |
Device Name |
COBAS READY TRIGLYCERIDE REAGENT |
Applicant |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
ONE SUNSET AVE. |
MONTCLAIR,
NJ
07042
|
|
Applicant Contact |
ALEX WESOLOWSKI |
Correspondent |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
ONE SUNSET AVE. |
MONTCLAIR,
NJ
07042
|
|
Correspondent Contact |
ALEX WESOLOWSKI |
Regulation Number | 862.1705
|
Classification Product Code |
|
Date Received | 10/30/1989 |
Decision Date | 02/16/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|