21 C.F.R. § 864.5350
Microsedimentation centrifuge.
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.