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510(k) Data Aggregation
K Number
K001347Device Name
MERIDIAN-II AND MERDIAN-PLUSManufacturer
Date Cleared
2000-11-03
(189 days)
Product Code
Regulation Number
882.1540Type
TraditionalPanel
NeurologyReference & Predicate Devices
N/A
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Device Name :
MERIDIAN-II AND MERDIAN-PLUS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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