Device Classification Name |
Biuret (Colorimetric), Total Protein
|
510(k) Number |
K884703 |
Device Name |
TOTAL PROTEIN TEST (TP) ITEM #65670 |
Applicant |
EM DIAGNOSTIC SYSTEMS, INC. |
480 DEMOCRAT RD. |
GIBBSTOWN,
NJ
08027
|
|
Applicant Contact |
ANNA G BENTLEY |
Correspondent |
EM DIAGNOSTIC SYSTEMS, INC. |
480 DEMOCRAT RD. |
GIBBSTOWN,
NJ
08027
|
|
Correspondent Contact |
ANNA G BENTLEY |
Regulation Number | 862.1635
|
Classification Product Code |
|
Date Received | 11/09/1988 |
Decision Date | 01/23/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|