Device Classification Name |
biuret (colorimetric), total protein
|
510(k) Number |
K813536 |
Device Name |
ASTRA TOTAL PROTEIN REAGENT |
Applicant |
HI CHEM, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
HI CHEM, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1635
|
Classification Product Code |
|
Date Received | 12/18/1981 |
Decision Date | 12/31/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|