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510(k) Data Aggregation
K Number
K963346Manufacturer
Date Cleared
1996-09-09
(14 days)
Product Code
Regulation Number
862.1660Type
TraditionalPanel
Clinical ChemistryReference & Predicate Devices
N/A
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Device Name :
STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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