Unistrip Technologies LLC
FDA Regulatory Profile
Unistrip Technologies LLC 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-0855-2015, Class II) was initiated on November 20, 2014. Its most recent 510(k) clearance was granted on November 6, 2013.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0855-2015 | Class II | UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by peop | November 20, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K113135 | UNISTRIP 1 | November 6, 2013 |