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K Number
K955570

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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
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
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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.