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510(k) Data Aggregation
K Number
K964385Device Name
ELIAS ANA-HEP-2Manufacturer
Date Cleared
1997-03-06
(122 days)
Product Code
Regulation Number
866.5100Type
TraditionalPanel
ImmunologyReference & Predicate Devices
N/A
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Device Name :
ELIAS ANA-HEP-2
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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