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510(k) Data Aggregation
K Number
K954006Manufacturer
Date Cleared
1996-03-12
(200 days)
Product Code
Regulation Number
864.5200Type
TraditionalPanel
HematologyReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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