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510(k) Data Aggregation
K Number
K003677Device Name
ABX PENTRA 60C+ HEMATOLOGY ANALYZERManufacturer
Date Cleared
2000-12-26
(27 days)
Product Code
Regulation Number
864.5220Type
SpecialPanel
HematologyReference & Predicate Devices
N/A
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Device Name :
ABX PENTRA 60C+ HEMATOLOGY ANALYZER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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