§ 862.2500. Enzyme analyzer for clinical use.
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/us/cfr/t21/s§ 862.2500·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An enzyme analyzer for clinical use is a device intended to measure enzymes in plasma or serum by nonkinetic or kinetic measurement of enzyme-catalyzed reactions. This device is used in conjunction with certain materials to measure a variety of enzymes as an aid in the diagnosis and treatment of certain enzyme-related disorders.
(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]