Gentian AS
Gentian AS appears in FDA public data with 1 recall, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0099-2021, Class II) was initiated on September 2, 2020. Its most recent 510(k) clearance was granted on August 20, 2008.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 2
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0099-2021 | Class II | GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cysta | September 2, 2020 |