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e-CFR data is current as of April 13, 2021

Title 21Chapter ISubchapter HPart 862Subpart B → §862.1560


Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems


§862.1560   Urinary phenylketones (nonquantitative) test system.

(a) Identification. A urinary phenylketones (nonquantitative) test system is a device intended to identify phenylketones (such as phenylpyruvic acid) in urine. The identification of urinary phenylketones is used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]

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