21 C.F.R. § 862.1175

Current through September 30, 2024
Section 862.1175 - Cholesterol (total) test system
(a)Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism 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 .

21 C.F.R. §862.1175

52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000