Device Classification Name |
Biuret (Colorimetric), Total Protein
|
510(k) Number |
K973108 |
Device Name |
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 |
Applicant |
DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, |
CHARLOTTETOWN, P.E.I.,
CA
C1E 2A6
|
|
Applicant Contact |
KAREN CALLBECK |
Correspondent |
DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, |
CHARLOTTETOWN, P.E.I.,
CA
C1E 2A6
|
|
Correspondent Contact |
KAREN CALLBECK |
Regulation Number | 862.1635
|
Classification Product Code |
|
Date Received | 08/19/1997 |
Decision Date | 03/02/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|