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K Number
K010984

Validate with FDA (Live)

Device Name
EMIT 2000 GENTAMICIN PLUS ASSAY
Manufacturer
SYVA CO., DADE BEHRING, INC.
Date Cleared
2001-04-20

(18 days)

Product Code
LCD
Regulation Number
862.3450
Type
Special
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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§ 862.3450 Gentamicin test system.

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