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510(k) Data Aggregation
K Number
K010061Manufacturer
Date Cleared
2001-03-14
(65 days)
Regulation Number
862.1600Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
Why did this record match?
Device Name :
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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