Title 21: Food and Drugs
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/ PART 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
/ Subpart C - Clinical Laboratory Instruments / § 862.2500 Enzyme analyzer for clinical use.
§ 862.2500 Enzyme analyzer for clinical use.
(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.