View all text of Subpart F [§ 864.5200 - § 864.5950]
§ 864.5240 - Automated blood cell diluting apparatus.
(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.