Device Classification Name |
Biuret (Colorimetric), Total Protein
|
510(k) Number |
K853932 |
Device Name |
QUANTTEST TOTAL PROTEIN ASSAY |
Applicant |
QUANTIMETRIX CORP. |
4955 WEST 145 ST. |
HAWTHORNE,
CA
90250 -6703
|
|
Applicant Contact |
LYNETTE SCHNEIDER |
Correspondent |
QUANTIMETRIX CORP. |
4955 WEST 145 ST. |
HAWTHORNE,
CA
90250 -6703
|
|
Correspondent Contact |
LYNETTE SCHNEIDER |
Regulation Number | 862.1635 |
Classification Product Code |
|
Date Received | 09/24/1985 |
Decision Date | 12/19/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|