21 C.F.R. § 864.5350

Current through September 30, 2024
Section 864.5350 - Microsedimentation centrifuge
(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 .

21 C.F.R. §864.5350

45 FR 60598, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38789, July 25, 2001