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e-CFR data is current as of March 3, 2021

Title 21Chapter ISubchapter HPart 862Subpart C → §862.2800


Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart C—Clinical Laboratory Instruments


§862.2800   Refractometer for clinical use.

(a) Identification. A refractometer for clinical use is a device intended to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.

(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 the limitations in §862.9.

[52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995; 66 FR 38788, July 25, 2001]

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