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O.N. Diagnostics, LLC Warning Letter Details

Warning Letter

O.N. Diagnostics, LLC

O.N. Diagnostics, LLC, 1936 University Ave, Ste 280 Berkley , CA 94704 United States, (b)(6), (b)(7)(C)

Issue DateSeptember 01, 2026

FEI NumberN/A

Violations9

CountryUnited States

Issuing Office

Center for Devices and Radiological Health

Product Type

Medical Devices

Status

Open

Subject

Medical Device Reporting/Misbranded

O.N. Diagnostics, LLC FDA Warning Letter, September 1, 2026