K Number
K010653Device Name
AT HOME DRUG TEST, MODEL 9068 TManufacturer
Date Cleared
2001-04-05
(31 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