Device Classification Name |
biuret (colorimetric), total protein
|
510(k) Number |
K770887 |
Device Name |
AUTO TOTAL PROTEIN FOR ANALYZER |
Applicant |
HARLECO |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
HARLECO |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 862.1635
|
Classification Product Code |
|
Date Received | 05/16/1977 |
Decision Date | 07/14/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|