Device Classification Name |
biuret (colorimetric), total protein
|
510(k) Number |
K871975 |
Device Name |
MULTICHEM TOTAL PROTEIN REAGENT #S0928 |
Applicant |
SIMMLER, INC. |
POST OFFICE BOX 25179 |
ST. LOUIS,
MO
63125
|
|
Applicant Contact |
KAREN E TIDD |
Correspondent |
SIMMLER, INC. |
POST OFFICE BOX 25179 |
ST. LOUIS,
MO
63125
|
|
Correspondent Contact |
KAREN E TIDD |
Regulation Number | 862.1635
|
Classification Product Code |
|
Date Received | 05/22/1987 |
Decision Date | 06/05/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|