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K Number
K003664

Validate with FDA (Live)

Device Name
DELFIA NEONATAL IRT KIT, MODEL A005-110
Manufacturer
WALLAC OY
Date Cleared
2001-02-14

(78 days)

Product Code
CGZ
Regulation Number
862.1170
Type
Traditional
Panel
Clinical Chemistry
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K051435,K991806
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 862.1170 Chloride test system.

(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.