21 C.F.R. § 862.2750

Current through November 30, 2024
Section 862.2750 - Pipetting and diluting system for clinical use
(a)Identification. A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.
(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. §862.2750

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