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AseptiKits, LLC

FDA Warning Letter · 2026-06-30 · Center for Devices and Radiological Health

Letter

Company
AseptiKits, LLC
Posted Date
2026-06-30
Letter Issue Date
2026-06-04
Issuing Office
Center for Devices and Radiological Health

Subject

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

Source

Authoritative
FDA Warning Letters
Machine
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