21 C.F.R. § 862.1450

Current through September 30, 2024
Section 862.1450 - Lactic acid test system
(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 .

21 C.F.R. §862.1450

52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000