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510(k) Data Aggregation
Device Name
Bio Arterial Deluxe (IC-BAP-DX)Manufacturer
Date Cleared
2025-12-12
(256 days)
Product Code
Regulation Number
870.5800Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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