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510(k) Data Aggregation
K Number
K955814Device Name
CEDIA DAU LSD ASSAYManufacturer
Date Cleared
1996-02-09
(45 days)
Product Code
Regulation Number
862.3580Type
TraditionalPanel
ToxicologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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