K Number
K964355Device Name
ONTRAK TESTCUP 5 (MODIFICATION)Manufacturer
Date Cleared
1996-12-13
(42 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
TXReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A