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510(k) Data Aggregation
K Number
K011323Manufacturer
Date Cleared
2001-12-17
(230 days)
Product Code
Regulation Number
862.1205Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
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Device Name :
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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