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K Number
K960437

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Device Name
RADIAS PHENYLALANINE TEST
Manufacturer
BIO-RAD
Date Cleared
1996-08-16

(198 days)

Product Code
JNB
Regulation Number
862.1555
Type
Traditional
Panel
Clinical Chemistry
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
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§ 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.