Title 21

SECTION 864.9575

864.9575 Environmental chamber for storage of platelet concentrate.

§ 864.9575 Environmental chamber for storage of platelet concentrate.

(a) Identification. An environmental chamber for storage of platelet concentrate is a device used to hold platelet-rich plasma within a preselected temperature range.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

[45 FR 60648, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]

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