Data / Medical devices / United States / Unistrip Technologies, LLC
Unistrip Technologies, LLC: FDA-registered device maker in Huntersville, NC, United States, 1 510(k) clearance
Unistrip Technologies, LLC is registered with the FDA (registration 3010622184) in Huntersville, NC, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 19, 2017. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010622184
- Address
- 11621 Patterson Road Suite 230, Huntersville, NC, United States, 28078
- Owner or operator
- UniStrip Technologies, LLC (10046018)
- Roles
- Complaint file establishment
- First device listed
- December 11, 2019
- Registered through
- 2026
- Brand names listed
- UniStrip1 Generic Blood Glucose Test Strips
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 19, 2017 | K162430 | UniStrip1 Generic Blood Glucose Test Strips | NBW | Substantially Equivalent | Ok Biotech Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 20, 2014 | 69856 | Class II | Terminated | 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. | Failure to submit a 510(k) for device labeling changes. | accessdata.fda.gov |
Compare with other makers
Updated January 19, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.