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510(k) Data Aggregation
Device Name
K.E.A.T.Manufacturer
Date Cleared
2001-03-22
(248 days)
Product Code
Regulation Number
876.5320Type
TraditionalAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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