§ 862.1450. Lactic acid test system.
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/us/cfr/t21/s§ 862.1450·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
(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 2307, Jan. 14, 2000]