{"data":{"id":"us/21-cfr-862.1150","jurisdiction":"us","citation":"21 CFR 862.1150","heading":"Calibrator.","body":"(a) Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)\n(b) Classification. Class II (special 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":"ec516112d4a479f90e006febe46c646abd78dfca68c50f7ed42842dc8d4db51a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-862.1145","next":"us/21-cfr-862.1155"},"notice":"GroundRules: Original legal text. Not legal advice."}