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510(k) Data Aggregation
K Number
K963938Device Name
MODEL 5500 CEASManufacturer
Date Cleared
1996-12-26
(86 days)
Product Code
Regulation Number
862.1165Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
Why did this record match?
Device Name :
MODEL 5500 CEAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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