{"data":{"id":"us/21-cfr-862.2300","jurisdiction":"us","citation":"21 CFR 862.2300","heading":"Colorimeter, photometer, or spectrophotometer for clinical use.","body":"(a) Identification. A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.\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 § 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":"6237edf3aaf1fc298c2888ca97410567ddf62acf783b36133e8f9feacee40e8b","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.2270","next":"us/21-cfr-862.2310"},"notice":"GroundRules: Original legal text. Not legal advice."}