21 C.F.R. § 864.5850

Automated slide spinner.

Last amended: 2016Year: 2026Length: 90 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 864.5850 (2026)

(a) Identification. An automated slide spinner is a device that prepares automatically a blood film on a microscope slide using a small amount of peripheral blood (blood circulating in one of the body's extremities, such as the arm). (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 60603, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]
Cross-references to the CFR
864.9.
21 C.F.R. § 864.5850: Automated slide spinner. | Justis AI