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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
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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.