The following data is part of a premarket notification filed by Wiener Laboratories S.a.i.c. with the FDA for Wiener Lab.mg-color Aa, Model 2x50 Ml Cat. N 1580001.
| Device ID | K012326 |
| 510k Number | K012326 |
| Device Name: | WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 |
| Classification | Photometric Method, Magnesium |
| 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 | JGJ |
| CFR Regulation Number | 862.1495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-23 |
| Decision Date | 2001-11-08 |
| Summary: | summary |