(a) Identification. An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further 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 60596, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]