K Number
DEN210033

Validate with FDA (Live)

Date Cleared
2023-03-06

(565 days)

Product Code
Regulation Number
874.3410
Type
Direct
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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N/A