21 C.F.R. § 864.5240

Current through September 30, 2024
Section 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 .

21 C.F.R. §864.5240

45 FR 60596, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000