21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1450

Lactic acid test system.

Title 21 C.F.R. ● ACTIVE Primary Source
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21 C.F.R. § 862.1450 — Lactic acid test system.

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

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21 C.F.R. § 862.1450
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The regulatory text of 21 C.F.R. § 862.1450 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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