K Number
K071444
Manufacturer
Date Cleared
2007-07-27

(64 days)

Product Code
Regulation Number
890.3850
Reference & 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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