§ 864.8200. Blood cell diluent.
73 words·~1 min read·
/us/cfr/t21/s§ 864.8200·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.
(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 60635, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]