21 C.F.R. § 864.5240 Automated blood cell diluting apparatus.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F—Automated and Semi-Automated Hematology Devices
§ 864.5240 Automated blood cell diluting apparatus.
