Title 21

SECTION 864.8500

864.8500 Lymphocyte separation medium.

§ 864.8500 Lymphocyte separation medium.

(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]

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