 |
Code of Federal Regulations (Last Updated: July 5, 2024) |
 |
Title 21 - Food and Drugs |
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
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.
Latest version.
-
§ 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]