The following data is part of a premarket notification filed by Wiener Laboratories S.a.i.c. with the FDA for Wiener Lab. Ca-color Arsenazo Iii Aa, Model 4x50 Ml Cat.nr. 1152004, Wiener Lab.ca-color Arsenazo Iii Aa, Model 8 X 20 5.
| Device ID | K021334 |
| 510k Number | K021334 |
| Device Name: | WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5 |
| Classification | Azo Dye, Calcium |
| 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 | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-26 |
| Decision Date | 2002-09-10 |
| Summary: | summary |