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510(k) Data Aggregation
K Number
K010953Device Name
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAYManufacturer
Date Cleared
2001-06-06
(68 days)
Product Code
Regulation Number
864.5220Type
TraditionalPanel
HematologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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