{"data":{"id":"us/21-cfr-862.1300","jurisdiction":"us","citation":"21 CFR 862.1300","heading":"Follicle-stimulating hormone test system.","body":"(a) Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.\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 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":"e09cb49570888e6c3499a1f966a6abad8b6d6a4e5262624df1d7da698a4d8bdb","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1295","next":"us/21-cfr-862.1305"},"notice":"GroundRules: Original legal text. Not legal advice."}