The following data is part of a premarket notification filed by Wiener Laboratories S.a.i.c. with the FDA for Wiener Lab.fer-color Aa, Model 5x 20 Ml Cat.n 1492003.
| Device ID | K013097 |
| 510k Number | K013097 |
| Device Name: | WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 |
| Classification | Photometric Method, Iron (non-heme) |
| 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 | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-17 |
| Decision Date | 2001-11-13 |
| Summary: | summary |