K Number
K002776Device Name
MODIFICATION TO PROFILE -IIManufacturer
Date Cleared
2000-09-28
(22 days)
Regulation Number
N/AType
SpecialPanel
ToxicologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A