§864.9575. Environmental chamber for storage of platelet concentrate.
21 C.F.R. § 864.9575
Identification. An environmental chamber for storage of platelet concentrate is a device used to hold platelet-rich plasma within a preselected temperature range.
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.
Notes, amendments, and revision history
Amendments
[45 FR 60648, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60648, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]