Device Classification Name |
biuret (colorimetric), total protein
|
510(k) Number |
K861508 |
Device Name |
WAKO MICRO TP |
Applicant |
WAKO CHEMICALS, USA, INC. |
12300 FORD RD. |
SUITE 130 |
DALLAS,
TX
75234
|
|
Applicant Contact |
TOSHIHIKO ODA |
Correspondent |
WAKO CHEMICALS, USA, INC. |
12300 FORD RD. |
SUITE 130 |
DALLAS,
TX
75234
|
|
Correspondent Contact |
TOSHIHIKO ODA |
Regulation Number | 862.1635
|
Classification Product Code |
|
Date Received | 04/23/1986 |
Decision Date | 08/19/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|