PHENYLALANINE TEST KIT

• K Number: K943547
• Device Name: PHENYLALANINE TEST KIT
• Manufacturer: ISOLAB, INC.
• Date Cleared: 1996-01-26 ( 554 days)
• Product Code: JNB
• Regulation Number: 862.1555
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 862.1555 Phenylalanine test system.

(a)
Identification. A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.(b)
Classification. Class II.