The following data is part of a premarket notification filed by Wiener Laboratories S.a.i.c. with the FDA for Wiener Lab. Uricostat Enzimatico Aa, Models 2x50 Ml Catalogue No 1840106 And 4x50 Ml Catalogue No 1840105.
| Device ID | K010421 |
| 510k Number | K010421 |
| Device Name: | WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA Rosario, AR 2000 |
| Contact | Viviana Cetola |
| Correspondent | Viviana Cetola WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA Rosario, AR 2000 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-12 |
| Decision Date | 2001-04-13 |