21 CFR § 864.5620 - Automated hemoglobin system.

---
identifier: "/us/cfr/t21/s864.5620"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.5620 - Automated hemoglobin system."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.5620"
section_name: "Automated hemoglobin system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---


# 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]