eCFR Reference Browser

---

title: "21 CFR §864.5620"

source: "https://www.ecfr.gov/current/title-21/section-864.5620"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "864"

part_subject: "HEMATOLOGY AND PATHOLOGY DEVICES"

subpart_code: "F"

subpart_subject: "Automated and Semi-Automated Hematology Devices"

section_number: "864.5620"

section_subject: "Automated hemoglobin system."

cfr_reference: "21 CFR 864.5620"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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).

§864.5620 - Automated hemoglobin system.