21 C.F.R. § 864.8200 Blood cell diluent.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart I—Hematology Reagents
§ 864.8200 Blood cell diluent.
