The following data is part of a premarket notification filed by Wiener Laboratories with the FDA for Wiener Lab. Standatrol S-e 2 Niveles, Lovels 1&2: 3x5 Ml Vials Cat.nr.1937553.
Device ID | K030482 |
510k Number | K030482 |
Device Name: | WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | WIENER LABORATORIES 2944 RIOBAMBA Rosario, AR 2000 |
Contact | Viviana Cetola |
Correspondent | Viviana Cetola WIENER LABORATORIES 2944 RIOBAMBA Rosario, AR 2000 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-13 |
Decision Date | 2003-03-19 |
Summary: | summary |