LogoFDA 510(k) Search
K Number
K950481

Validate with FDA (Live)

Device Name
NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT
Manufacturer
ISOLAB, INC.
Date Cleared
1996-02-01

(363 days)

Product Code
JIA
Regulation Number
862.1310
Type
Traditional
Panel
Clinical Chemistry
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

§ 862.1310 Galactose test system.

(a)
Identification. A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.(b)
Classification. Class I.