Device Classification Name |
biuret (colorimetric), total protein
|
510(k) Number |
K844331 |
Device Name |
TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER |
Applicant |
ADVANCED BIOMEDICAL METHODS, INC. |
P.O. BOX 48026 |
NILES,
IL
60648
|
|
Applicant Contact |
JACK M GOLDBERG |
Correspondent |
ADVANCED BIOMEDICAL METHODS, INC. |
P.O. BOX 48026 |
NILES,
IL
60648
|
|
Correspondent Contact |
JACK M GOLDBERG |
Regulation Number | 862.1635
|
Classification Product Code |
|
Date Received | 11/07/1984 |
Decision Date | 01/03/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|