Device Classification Name |
biuret (colorimetric), total protein
|
510(k) Number |
K941496 |
Device Name |
SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY |
Applicant |
SOLARCARE, INC. |
1745 EATON AVE. |
BETHLEHEM,
PA
18018 -1799
|
|
Applicant Contact |
R. SAM NIEDBALA |
Correspondent |
SOLARCARE, INC. |
1745 EATON AVE. |
BETHLEHEM,
PA
18018 -1799
|
|
Correspondent Contact |
R. SAM NIEDBALA |
Regulation Number | 862.1635
|
Classification Product Code |
|
Date Received | 03/28/1994 |
Decision Date | 10/27/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|