21 C.F.R. · Food and Drugs
21 C.F.R. § 864.5620

Automated hemoglobin system.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 864.5620 — Automated hemoglobin system.

§ 864.5620 Automated hemoglobin system. (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]

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21 C.F.R. § 864.5620
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The regulatory text of 21 C.F.R. § 864.5620 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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