Device Classification Name |
phosphomolybdate (colorimetric), inorganic phosphorus
|
510(k) Number |
K013095 |
Device Name |
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 |
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 | 862.1580
|
Classification Product Code |
|
Date Received | 09/17/2001 |
Decision Date | 11/16/2001 |
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
|
|
|