Data / Medical devices / United States / Nxtscreen LLC
Nxtscreen LLC: FDA-registered device maker in Littleton, CO, United States, 1 510(k) clearance
Nxtscreen LLC is registered with the FDA (registration 3042364147) in Littleton, CO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 19, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042364147
- Address
- 10 Holly Oak, Littleton, CO, United States, 80127
- Owner or operator
- NXTSCREEN LLC (10094431)
- Roles
- Complaint file establishment
- First device listed
- November 28, 2025
- Registered through
- 2026
- Brand names listed
- GLUCO BLOOD GLUCOSE METER
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| December 19, 2018 | K173140 | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System | NBW | Substantially Equivalent | Vivachek Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 19, 2018. 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.