K Number
K001160
Date Cleared
2000-12-11

(245 days)

Product Code
Regulation Number
888.3027
Reference & 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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N/A