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510(k) Data Aggregation
K Number
K003843Device Name
ENVIVE MINIFORMSManufacturer
Date Cleared
2001-02-08
(58 days)
Product Code
Regulation Number
884.5435Type
TraditionalReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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