LogoFDA 510(k) Search
K Number
K955716

Validate with FDA (Live)

Device Name
VANCOMYCIN FPIA REAGENT SET
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
1996-02-16

(63 days)

Product Code
LEH
Regulation Number
862.3950
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
AI/ML Overview

Loading...

§ 862.3950 Vancomycin test system.

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