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510(k) Data Aggregation
K Number
K001411Manufacturer
Date Cleared
2000-08-21
(109 days)
Product Code
Regulation Number
862.1545Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
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Device Name :
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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