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510(k) Data Aggregation
K Number
DEN240020Device Name
Visby Medical Women's Sexual Health TestManufacturer
Date Cleared
2025-03-28
(319 days)
Product Code
Regulation Number
866.3386Type
DirectPanel
MicrobiologyReference & Predicate Devices
N/A
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Product Code :
SEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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