Device Classification Name |
biuret (colorimetric), total protein
|
510(k) Number |
K896916 |
Device Name |
CLINISTAT TOTAL PROTEIN REAGENT TEST |
Applicant |
HERAEUS KULZER, INC. |
DIAGNOSTICS DIVISION |
P.O. BOX 70 |
ELKHART,
IN
46515
|
|
Applicant Contact |
ROSANNE SAVOL |
Correspondent |
HERAEUS KULZER, INC. |
DIAGNOSTICS DIVISION |
P.O. BOX 70 |
ELKHART,
IN
46515
|
|
Correspondent Contact |
ROSANNE SAVOL |
Regulation Number | 862.1635
|
Classification Product Code |
|
Date Received | 12/11/1989 |
Decision Date | 01/19/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|