21 C.F.R. § 864.5350

Microsedimentation centrifuge.

Last amended: 2016Year: 2026Length: 70 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 864.5350 (2026)

(a) Identification. A microsedimentation centrifuge is a device used to sediment red cells for the microsedimentation rate test. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. [45 FR 60598, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38789, July 25, 2001]
Cross-references to the CFR
864.9.
21 C.F.R. § 864.5350: Microsedimentation centrifuge. | Justis AI