Wiener Laboratories
FDA Regulatory Profile
Wiener Laboratories appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0924-2018, Class II) was initiated on November 10, 2017. Its most recent 510(k) clearance was granted on March 19, 2003.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0924-2018 | Class II | Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease. | November 10, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K030482 | WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 | March 19, 2003 |