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510(k) Data Aggregation
Device Name
QUANTA FLASH H-TTG IGAManufacturer
Date Cleared
2010-10-13
(286 days)
Regulation Number
866.5660Type
TraditionalPanel
ImmunologyAge 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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