21 C.F.R. § 864.3300

Cytocentrifuge.

Last amended: 2016Year: 2026Length: 83 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 864.3300 (2026)

(a) Identification. A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g., cerebrospinal fluid) and to deposit these cells on a glass microscope slide for cytological examination. (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 60588, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 66 FR 38789, July 25, 2001]
Cross-references to the CFR
864.9.
21 C.F.R. § 864.3300: Cytocentrifuge. | Justis AI