21 C.F.R. · Food and Drugs
21 C.F.R. § 864.9275

Blood bank centrifuge for in vitro diagnostic use.

Title 21 C.F.R. ● ACTIVE Primary Source
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21 C.F.R. § 864.9275 — Blood bank centrifuge for in vitro diagnostic use.

§ 864.9275 Blood bank centrifuge for in vitro diagnostic use. (a) Identification. A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells for further diagnostic testing. (b) Classification. Class I (general 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 60645, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]

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21 C.F.R. § 864.9275
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The regulatory text of 21 C.F.R. § 864.9275 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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