{"data":{"id":"us/21-cfr-862.1575","jurisdiction":"us","citation":"21 CFR 862.1575","heading":"Phospholipid test system.","body":"(a) Identification. A phospholipid test system is a device intended to measure phospholipids in serum and plasma. Measurements of phospholipids are used in the diagnosis and treatment of disorders involving lipid (fat) metabolism.\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 B—Clinical Chemistry Test Systems"],"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":"783072a90473afd738522c305499db572c00c4b4ab117057bccd2c109963e2f9","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1570","next":"us/21-cfr-862.1580"},"notice":"GroundRules: Original legal text. Not legal advice."}