The following data is part of a premarket notification filed by Wiener Laboratories S.a.i.c. with the FDA for Wiener Lab. Glicemia Enzimatica Aa Models 1 X 250 Ml Cat. #1400106; 4 250 Ml Cat. # 1400107; Wiener Lab. Gilicemia Enzca.
| Device ID | K011953 |
| 510k Number | K011953 |
| Device Name: | WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA |
| Classification | Glucose Oxidase, Glucose |
| 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 | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-21 |
| Decision Date | 2001-12-21 |
| Summary: | summary |