{"data":{"id":"us/21-cfr-864.5620","jurisdiction":"us","citation":"21 CFR 864.5620","heading":"Automated hemoglobin system.","body":"(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.\n(b) Classification. Class II (performance standards).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 864—HEMATOLOGY AND PATHOLOGY DEVICES","Subpart F—Automated and Semi-Automated Hematology Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"4409a17b2bb704ceee3e9caa855268307caf70ff0dd1230bbf0ad2205402c201","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.5600","next":"us/21-cfr-864.5680"},"notice":"GroundRules: Original legal text. Not legal advice."}