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510(k) Data Aggregation
K Number
K001761Device Name
STATLYTE NA/K/CL/LI ANALYZERManufacturer
Date Cleared
2000-08-07
(59 days)
Regulation Number
862.1665Type
TraditionalPanel
Clinical ChemistryReference & 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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