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510(k) Data Aggregation
K Number
K000810Device Name
QUALITROL LIPID CONTROL, LEVELS 1 AND 2Manufacturer
Date Cleared
2000-04-13
(31 days)
Product Code
Regulation Number
862.1660Type
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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