The following data is part of a premarket notification filed by Wiener Laboratorios S.a.i.c. with the FDA for Wiener Lab. Urine Strip 10 And 11.
| Device ID | K083724 |
| 510k Number | K083724 |
| Device Name: | WIENER LAB. URINE STRIP 10 AND 11 |
| Classification | Blood, Occult, Colorimetric, In Urine |
| Applicant | WIENER LABORATORIOS S.A.I.C. 2944 RIOBAMBA Rosario, AR 2000 |
| Contact | Vivina Cetola |
| Correspondent | Vivina Cetola WIENER LABORATORIOS S.A.I.C. 2944 RIOBAMBA Rosario, AR 2000 |
| Product Code | JIO |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMA |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-15 |
| Decision Date | 2009-09-02 |
| Summary: | summary |