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510(k) Data Aggregation
Device Name
PROFILE-ERManufacturer
Date Cleared
2001-01-17
(169 days)
Regulation Number
862.3150Type
TraditionalPanel
ToxicologyAge 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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