Quantimetrix Corporation
FDA Regulatory Profile
Quantimetrix Corporation appears in FDA public data with 1 recall, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2257-2018, Class III) was initiated on December 21, 2017. Its most recent 510(k) clearance was granted on April 21, 2016.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2257-2018 | Class III | Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of | December 21, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K152117 | Dropper hsCRP High Sensitivity CRP Control | April 21, 2016 |