21 C.F.R. · Food and Drugs
21 C.F.R. § 864.9575

Environmental chamber for storage of platelet concentrate.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 864.9575 — Environmental chamber for storage of platelet concentrate.

§ 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]

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21 C.F.R. § 864.9575
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The regulatory text of 21 C.F.R. § 864.9575 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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