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510(k) Data Aggregation
K Number
K961470Device Name
PORT-A-POLEManufacturer
Date Cleared
1996-07-22
(96 days)
Product Code
Regulation Number
880.6990Type
TraditionalPanel
Hematology (HO)Reference & Predicate Devices
N/A
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Device Name :
PORT-A-POLE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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