{"data":{"id":"us/21-cfr-862.2800","jurisdiction":"us","citation":"21 CFR 862.2800","heading":"Refractometer for clinical use.","body":"(a) Identification. A refractometer for clinical use is a device intended to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.\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":"95e9e253e29850c13391ccccaa359ba243070809a0588deb54bd920217ad4da6","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.2750","next":"us/21-cfr-862.2850"},"notice":"GroundRules: Original legal text. Not legal advice."}