(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 Sec. 864.9. [45 FR 60645, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]