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510(k) Data Aggregation

K Number

Device Name

IsoSphere

Manufacturer

IsoAid, LLC

Date Cleared

2025-07-15

(300 days)

Product Code

KXK

Regulation Number

892.5730

Why did this record match?

Applicant Name (Manufacturer) :

IsoAid, LLC

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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