View all text of Subpart I [§ 864.8100 - § 864.8950]
§ 864.8200 - Blood cell diluent.
(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.