§864.8500. Lymphocyte separation medium.
21 C.F.R. § 864.8500
Identification. A lymphocyte separation medium is a device used to isolate lymphocytes from whole blood.
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.
Notes, amendments, and revision history
Amendments
[45 FR 60636, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60636, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, 2001]