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510(k) Data Aggregation
K Number
K090920Manufacturer
Date Cleared
2009-12-30
(273 days)
Product Code
Regulation Number
866.5510Type
TraditionalPanel
Immunology (IM)Reference & Predicate Devices
N/A
Why did this record match?
Device Name :
HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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