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510(k) Data Aggregation
Manufacturer
Date Cleared
2001-01-22
(89 days)
Regulation Number
862.3900Type
TraditionalPanel
Clinical ChemistryAge 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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