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e-CFR data is current as of April 14, 2021

Title 21Chapter ISubchapter HPart 862Subpart B → §862.1650


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


§862.1650   Pyruvate kinase test system.

(a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells). Measurements obtained by this device are used in the diagnosis and treatment of various inherited anemias due to pyruvate kinase deficiency or of acute leukemias.

(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 2308, Jan. 14, 2000]

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