Device Classification Name |
Berthelot Indophenol, Urea Nitrogen
|
510(k) Number |
K893128 |
Device Name |
STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 |
Applicant |
STANBIO LABORATORY |
2930 EAST HOUSTON ST. |
SAN ANTONIO,
TX
78202
|
|
Applicant Contact |
WILLIAM J CAMPBELL |
Correspondent |
STANBIO LABORATORY |
2930 EAST HOUSTON ST. |
SAN ANTONIO,
TX
78202
|
|
Correspondent Contact |
WILLIAM J CAMPBELL |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 04/25/1989 |
Decision Date | 07/25/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|