21 C.F.R. § 864.8500 Lymphocyte separation medium.
Title 21 - Food and Drugs
(a) Identification. A lymphocyte separation medium is a device used to isolate lymphocytes from whole blood. (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 60636, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, 2001]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart I—Hematology Reagents
§ 864.8500 Lymphocyte separation medium.
