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510(k) Data Aggregation
K Number
K070789Device Name
EUROIMMUN ANTI-CCP ELISAManufacturer
Date Cleared
2007-12-31
(284 days)
Product Code
Regulation Number
866.5775Type
TraditionalPanel
ImmunologyReference & Predicate Devices
N/A
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Device Name :
EUROIMMUN ANTI-CCP ELISA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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