Unistrip Technologies, LLC

Medical device manufacturer in Charlotte, NC.

1510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K113135Unistrip 1NBW · Traditional 11/06/2013SE

Recalls

RecallProductInitiated
Z-0855-2015 Class IIUniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for…Failure to submit a 510(k) for device labeling changes. 11/20/2014Terminated