Manufacturer
Date Cleared
2013-07-12
(675 days)
Product Code
Regulation Number
880.2805Type
Post-NSEPanel
General HospitalAge 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