21 C.F.R. § 862.2680

Current through October 31, 2024
Section 862.2680 - Microtitrator for clinical use
(a)Identification. A microtitrator for clinical use is a device intended for use in micronanalysis to measure the concentration of a substance by reacting it with a measure "micro" volume of a known standardized solution.
(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. §862.2680

52 FR 16122, May 1, 1987, as amended at 65 FR 2309 , Jan. 14, 2000