Who is the manufacturer of PHENYLALANINE TEST KIT?

Isolab, Inc. submitted the Traditional clearance for PHENYLALANINE TEST KIT (K943547).

What is the FDA product code for PHENYLALANINE TEST KIT?

JNB. It is classified under 21 CFR 862.1555 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for PHENYLALANINE TEST KIT?

510(k) clearance (submission type: Traditional).

PHENYLALANINE TEST KIT

K943547 · Isolab, Inc. · JNB · Jan 26, 1996 · Clinical Chemistry

Device Facts

Record ID	K943547
Device Name	PHENYLALANINE TEST KIT
Applicant	Isolab, Inc.
Product Code	JNB · Clinical Chemistry
Decision Date	Jan 26, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1555
Device Class	Class 2

Regulatory Classification

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.