Opgen Inc
FDA Regulatory Profile
Opgen Inc appears in FDA public data with 2 recalls, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1328-2019, Class II) was initiated on March 18, 2019. Its most recent 510(k) clearance was granted on September 30, 2021.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1328-2019 | Class II | CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control S | March 18, 2019 |
| Z-2439-2018 | Class II | AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalo | May 14, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K191288 | Acuitas AMR Gene Panel | September 30, 2021 |