Text
Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER H: MEDICAL DEVICES
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.
(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]
Sponsored links
