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510(k) Data Aggregation
K Number
K010220Device Name
XTRACTOR, MODEL M143Manufacturer
Date Cleared
2001-04-09
(75 days)
Product Code
Regulation Number
876.1500Type
TraditionalReference & Predicate Devices
N/A
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Device Name :
XTRACTOR, MODEL M143
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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