# FDA Warning Letter: O.N. Diagnostics, LLC
> 2026-10-06 · Center for Devices and Radiological Health · `3556a29bf53f72eb`
## Letter
- **Company:** O.N. Diagnostics, LLC
- **Posted Date:** 2026-10-06
- **Letter Issue Date:** 2026-09-01
- **Issuing Office:** Center for Devices and Radiological Health
## Subject
Medical Device Reporting/Misbranded
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*Source: [FDA Warning Letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters) · MORVS · CC0 1.0*