K Number
K010175

Validate with FDA (Live)

Date Cleared
2002-02-06

(384 days)

Product Code
Regulation Number
890.5500
Age Range
N/A
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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N/A