Device product
UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Z-0855-2015
Product summary
- Event
- Event 69856
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7175 units
- Official record key
device-enforcement:Z-0855-2015
Official wording
Reason: Failure to submit a 510(k) for device labeling changes.
Code information: U14030713, 814031313, U140312323, and U14031413.
Distribution pattern: US Distribution to the states of FL and OH.
Derived failure modes
-
Unknown
Failure to submit a 510(k) for device labeling changes.