21 C.F.R. § 864.9575 Environmental chamber for storage of platelet concentrate.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
§ 864.9575 Environmental chamber for storage of platelet concentrate.
