Device Classification Name |
Biuret (Colorimetric), Total Protein
|
510(k) Number |
K832169 |
Device Name |
TOTAL PROTEIN PROCEDURE |
Applicant |
SANDARE CHEMICAL CO., INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SANDARE CHEMICAL CO., INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 862.1635
|
Classification Product Code |
|
Date Received | 07/06/1983 |
Decision Date | 08/16/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|