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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

Assert-IQ (DM5100)

Manufacturer

Date Cleared

2025-12-18

(36 days)

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Regulation Number

Type

Panel

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N/A

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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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