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510(k) Data Aggregation
K Number
K950342Device Name
TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCPManufacturer
Date Cleared
1996-02-20
(389 days)
Product Code
Regulation Number
864.5220Type
TraditionalPanel
HematologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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