21 C.F.R. § 862.2150

Current through October 31, 2024
Section 862.2150 - Continuous flow sequential multiple chemistry analyzer for clinical use
(a)Identification. A continuous flow sequential multiple chemistry analyzer for clinical use is a modular analytical instrument intended to simultaneously perform multiple chemical procedures using the principles of automated continuous flow systems. This device is intended for use in conjunction with certain materials to measure a variety of analytes.
(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. §862.2150

52 FR 16122, May 1, 1987, as amended at 65 FR 2308 , Jan. 14, 2000