K Number
K961266Device Name
ACCUSIGN, BIOSIGN PCPManufacturer
Date Cleared
1996-05-31
(59 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
ToxicologyReference & 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