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510(k) Data Aggregation
K Number
K951822Device Name
EBNA ENZYME IMMUNOASSAY KITManufacturer
Date Cleared
1996-02-15
(301 days)
Product Code
Regulation Number
866.3235Type
TraditionalPanel
MicrobiologyReference & Predicate Devices
N/A
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Device Name :
EBNA ENZYME IMMUNOASSAY KIT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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