21 CFR 864.9575
§ 864.9575 Environmental chamber for storage of platelet concentrate.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.9575, § 864.9575 Environmental chamber for storage of platelet concentrate, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89425
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.