21 C.F.R. § 864.5620 Automated hemoglobin system.
Title 21 - Food and Drugs
(a) Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood. (b) Classification. Class II (performance standards). [45 FR 60601, Sept. 12, 1980]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F—Automated and Semi-Automated Hematology Devices
§ 864.5620 Automated hemoglobin system.