21 C.F.R. · Food and Drugs
21 C.F.R. § 864.9700

Blood storage refrigerator and blood storage freezer.

Title 21 C.F.R. ● ACTIVE Primary Source
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21 C.F.R. § 864.9700 — Blood storage refrigerator and blood storage freezer.

§ 864.9700 Blood storage refrigerator and blood storage freezer. (a) Identification. A blood storage refrigerator and a blood storage freezer are devices intended for medical purposes that are used to preserve blood and blood products by storing them at cold or freezing temperatures. (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 60650, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998]

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21 C.F.R. § 864.9700
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The regulatory text of 21 C.F.R. § 864.9700 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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