CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART I—Hematology Reagents (§864.8100 to §864.8950) > 864.8200—Blood cell diluent.

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.

Code of Federal Regulations

[45 FR 60635, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]