Device Classification Name |
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
|
510(k) Number |
K873366 |
Device Name |
WAKO(TM) PRETEST 5A |
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 | 862.1785 |
Classification Product Code |
|
Date Received | 08/21/1987 |
Decision Date | 01/21/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|