LABSTYLE INNOVATIONS
LABSTYLE INNOVATIONS appears in FDA public data with 1 recall, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0260-2020, Class II) was initiated on August 29, 2019. Its most recent 510(k) clearance was granted on July 19, 2017.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 2
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0260-2020 | Class II | Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4. | August 29, 2019 |