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K Number
K970120
Device Name
BILE ACIDS REAGENT SET
Manufacturer
TECO DIAGNOSTICS
Date Cleared
1997-03-24

(69 days)

Product Code
KWW
Regulation Number
862.1177
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

§ 862.1177 Cholylglycine test system.

(a)
Identification. A cholylglycine test system is a device intended to measure the bile acid cholylglycine in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.(b)
Classification. Class II.