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510(k) Data Aggregation
Device Name
RUBICON PROTHROMBIN TIME MONITORING SYSTEMManufacturer
Date Cleared
2001-05-15
(347 days)
Product Code
Regulation Number
864.7750Type
TraditionalPanel
HematologyAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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