The following data is part of a premarket notification filed by Wiener Laboratories S.a.i.c. with the FDA for Wiener Lab. Bilirubina Direct Aa.
| Device ID | K024116 |
| 510k Number | K024116 |
| Device Name: | WIENER LAB. BILIRUBINA DIRECT AA |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA Rosario, AR 2000 |
| Contact | Viviana Cetila |
| Correspondent | Viviana Cetila WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA Rosario, AR 2000 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-13 |
| Decision Date | 2003-02-12 |
| Summary: | summary |