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

Title 21Chapter ISubchapter HPart 862Subpart C → §862.2700


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


§862.2700   Nephelometer for clinical use.

(a) Identification. A nephelometer for clinical use is a device intended to estimate the concentration of particles in a suspension by measuring their light scattering properties (the deflection of light rays by opaque particles in their path). The device is used in conjunction with certain materials to measure the concentration of a variety of analytes.

(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 2309, Jan. 14, 2000]

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