{"data":{"id":"us/21-cfr-862.2400","jurisdiction":"us","citation":"21 CFR 862.2400","heading":"Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.","body":"(a) Identification. A densitometer/scanner (integrating, reflectance, thin-layer chromatography, or radiochromatogram) for clinical use is device intended to measure the concentration of a substance on the surface of a film or other support media by either a photocell measurement of the light transmission through a given area of the medium or, in the case of the radiochromatogram scanner, by measurement of the distribution of a specific radio-active element on a radiochromatogram.\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":"142f3ad9ee2c711d96c9d05ada040f03bffbed20656ed2589d571522e8482b0c","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.2320","next":"us/21-cfr-862.2485"},"notice":"GroundRules: Original legal text. Not legal advice."}