Device Classification Name |
urease and glutamic dehydrogenase, urea nitrogen
|
510(k) Number |
K012260 |
Device Name |
WIENER LAB. UREA UV CINETICA AA |
Applicant |
WIENER LABORATORIES S.A.I.C. |
2944 RIOBAMBA |
ROSARIO,
AR
2000
|
|
Applicant Contact |
VIVIANA CETOLA |
Correspondent |
WIENER LABORATORIES S.A.I.C. |
2944 RIOBAMBA |
ROSARIO,
AR
2000
|
|
Correspondent Contact |
VIVIANA CETOLA |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 07/18/2001 |
Decision Date | 09/19/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|