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K Number
K955570
Device Name
INNOFLUOR AMIKACIN ASSAY SYSTEM
Manufacturer
OXIS INTL., INC.
Date Cleared
1996-02-09

(65 days)

Product Code
KLQ
Regulation Number
862.3035
Type
Traditional
Panel
Toxicology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 862.3035 Amikacin test system.

(a)
Identification. An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.(b)
Classification. Class II.