{"data":{"id":"us/21-cfr-862.2320","jurisdiction":"us","citation":"21 CFR 862.2320","heading":"Beta or gamma counter for clinical use.","body":"(a) Identification. A beta or gamma counter for clinical use is a device intended to detect and count beta or gamma radiation emitted by clinical samples. Clinical samples are prepared by addition of a radioactive reagent to the sample. These measurements are useful in the diagnosis and treatment of various disorders.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES","Subpart C—Clinical Laboratory Instruments"],"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":"6c692e42dd9e379b8088ac5937eacfc4a22802881d8d5cfe7bee05d229f16211","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.2310","next":"us/21-cfr-862.2400"},"notice":"GroundRules: Original legal text. Not legal advice."}