O.N. Diagnostics, LLC: FDA Warning Letter, Sep 1, 2026

Status: Unknown as of Oct 16, 2026. Warning letters are informal and advisory, not final agency action. Original on FDA.gov.

Company
O.N. Diagnostics, LLC (as published by FDA)
Letter date
Sep 1, 2026
Posted
Oct 6, 2026
Office
Center for Devices and Radiological Health
Subject
“Medical Device Reporting/Misbranded”
Response
None posted by FDA as of last check
Close-out
None posted by FDA as of last check
Source
FDA.gov · retrieved Oct 16, 2026

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Topics: Medical devices

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