21 CFR 862.2560 - Fluorometer for clinical use.

§ 862.2560 Fluorometer for clinical use.

(a)Identification. A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescence is the property of certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction with certain materials to measure 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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