§ 864.5850. Automated slide spinner.
90 words·~1 min read·
/us/cfr/t21/s§ 864.5850·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]