The following data is part of a premarket notification filed by Wiener Laboratories S.a.i.c. with the FDA for Wiener Lab. Got (ast) Uv Aa. Weiner Lab. Got (ast) Uv Unitest, Models 10 * 20 Ml Cat. Nr. 1751302 And 20 * 2 Ml Cat Nr..
| Device ID | K013145 |
| 510k Number | K013145 |
| Device Name: | WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR. |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| 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 | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-20 |
| Decision Date | 2001-11-27 |
| Summary: | summary |