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510(k) Data Aggregation
K Number
K083844Device Name
ADVIA CENTAUR TSH3-ULTRA METHODManufacturer
Date Cleared
2009-05-08
(135 days)
Product Code
Regulation Number
862.1690Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
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Device Name :
ADVIA CENTAUR TSH3-ULTRA METHOD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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