LogoFDA 510(k) Search
K Number
K955562
Device Name
INNOFLUOR PHENYTOIN ASSAY SYSTEM
Manufacturer
OXIS INTL., INC.
Date Cleared
1996-01-24

(49 days)

Product Code
LGR
Regulation Number
862.3350
Type
Traditional
Panel
TX
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 862.3350 Diphenylhydantoin test system.

(a)
Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.(b)
Classification. Class II.