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510(k) Data Aggregation
K Number
K010500Device Name
AUTOMATED WORKCELL CONTROL SOFTWAREManufacturer
Date Cleared
2001-08-01
(161 days)
Regulation Number
862.2160Type
TraditionalPanel
Clinical ChemistryReference & 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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