K Number
K010651Device Name
AT HOME DRUG TEST, MODEL 9133 TManufacturer
Date Cleared
2001-03-30
(25 days)
Product Code
Regulation Number
N/AType
SpecialPanel
TXReference & 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