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510(k) Data Aggregation
K Number
DEN230051Device Name
Myocene
Manufacturer
Date Cleared
2025-01-17
(540 days)
Product Code
Regulation Number
882.1871Why did this record match?
Product Code :
SDX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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