{"data":{"id":"us/21-cfr-862.2310","jurisdiction":"us","citation":"21 CFR 862.2310","heading":"Clinical sample concentrator.","body":"(a) Identification. A clinical sample concentrator is a device intended to concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid, and other body fluids before the fluids are analyzed.\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":"1f5ce592629d4c054098a71d5d008c763b705022124db875ac5dd0d19ea8e5b2","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.2300","next":"us/21-cfr-862.2320"},"notice":"GroundRules: Original legal text. Not legal advice."}